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A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

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ClinicalTrials.gov Identifier: NCT05418868
Recruitment Status : Recruiting
First Posted : June 14, 2022
Last Update Posted : January 8, 2024
Sponsor:
Information provided by (Responsible Party):
ViiV Healthcare

Study Description
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Brief Summary:
This is an open-label, dose-escalation study to investigate the safety, tolerability, and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A) and CAB 400 mg/mL without rHuPH20 (Part C) and CAB 400 mg/mL with rHuPH20 (Part D). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Cabotegravir 200 mg/mL Drug: Cabotegravir 400 mg/mL Drug: Recombinant human hyaluronidase PH20 (rHuPH20) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multi-centre, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Long-acting Cabotegravir Co-administered With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers
Actual Study Start Date : June 14, 2022
Estimated Primary Completion Date : November 11, 2025
Estimated Study Completion Date : November 12, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: Participants receiving CAB 200 mg/mL with rHuPH20
Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results.
 Drug: Cabotegravir 200 mg/mL
CAB 200 mg/mL will be administered.

Drug: Recombinant human hyaluronidase PH20 (rHuPH20)
rHuPH20 will be administered.
Experimental: Part C: Participants receiving CAB 400 mg/mL Drug: Cabotegravir 400 mg/mL
CAB 400 mg/mL will be administered.
Experimental: Part D: Participants receiving CAB 400 mg/mL with rHuPH20 Drug: Cabotegravir 400 mg/mL
CAB 400 mg/mL will be administered.

Drug: Recombinant human hyaluronidase PH20 (rHuPH20)
rHuPH20 will be administered.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of Cabotegravir [ Time Frame: Up to Week 52 ]
  2. Time of maximum observed plasma concentration (tmax) of Cabotegravir [ Time Frame: Up to Week 52 ]
  3. Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of Cabotegravir [ Time Frame: Up to Week 52 ]
  4. Area under the concentration - time curve from time zero to time of last quantifiable concentration or 4 weeks following the injection whichever is earlier (AUC[0-t]) of Cabotegravir [ Time Frame: Up to Week 52 ]
  5. Plasma Concentration of Cabotegravir at Week 4 [ Time Frame: Week 4 ]
  6. Plasma Concentration of Cabotegravir at Week 8 [ Time Frame: Week 8 ]
  7. Plasma Concentration of Cabotegravir at Week 12 [ Time Frame: Week 12 ]
  8. Plasma Concentration of Cabotegravir at Week 24 [ Time Frame: Week 24 ]
  9. Apparent terminal phase half-life (t1/2) of Cabotegravir [ Time Frame: Up to Week 52 ]
  10. Apparent long-acting absorption rate constant (KA-LA) of Cabotegravir [ Time Frame: Up to Week 52 ]
  11. Number of Participants with Non-serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 52 ]
  12. Number of Participants with AEs by Severity [ Time Frame: Up to Week 52 ]
  13. Absolute value of Hematology parameter: Platelet count (cells per microliter) [ Time Frame: Up to Week 52 ]
  14. Absolute values of Hematology parameters: Reticulocytes (Percentage of reticulocytes) [ Time Frame: Up to Week 52 ]
  15. Absolute values of Hematology parameters: Hematocrit (Proportion of red blood cells in blood) [ Time Frame: Up to Week 52 ]
  16. Absolute values of Hematology parameters: Hemoglobin (Hgb) (grams per deciliter) [ Time Frame: Up to Week 52 ]
  17. Absolute value of Hematology parameter: Red Blood Cell Count (RBC) (million cells per microliter) [ Time Frame: Up to Week 52 ]
  18. Absolute value of Hematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters) [ Time Frame: Up to Week 52 ]
  19. Absolute value of Hematology parameter: Mean Corpuscle Hemoglobin (MCH) (Picograms) [ Time Frame: Up to Week 52 ]
  20. Absolute values of Hematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter) [ Time Frame: Up to Week 52 ]
  21. Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per deciliter) [ Time Frame: Up to Week 52 ]
  22. Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter) [ Time Frame: Up to Week 52 ]
    Clinical chemistry parameters such as Aspartate Aminotransferase (AST) / Serum Glutamic-Oxaloacetic Transaminase (SGOT), Alanine Aminotransferase (ALT)/ Serum Glutamic-Pyruvic Transaminase and (SGPT), Alkaline phosphatase (ALP) and Creatinine Phosphokinase (CPK) will be analyzed.

  23. Absolute values of Clinical chemistry parameters: Albumin and Total Protein (Grams per deciliter) [ Time Frame: Up to Week 52 ]
  24. Change from Baseline in Hematology parameter: Platelet count (cells per microliter) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  25. Change from Baseline in Hematology parameters: Reticulocytes (Percentage of reticulocytes) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  26. Change from Baseline in Hematology parameters: Hematocrit (Proportion of red blood cells in blood) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  27. Change from Baseline in Hematology parameters: Hgb (grams per deciliter) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  28. Change from Baseline in Hematology parameter: RBC Count (million cells per microliter) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  29. Change from Baseline in Hematology parameter: MCV (Femtoliters) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  30. Change from Baseline in Hematology parameter: MCH (picograms) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  31. Change from Baseline in Hematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (Giga cells per liter) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  32. Change from Baseline in Clinical Chemistry parameters: Glucose (fasting), BUN, Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per deciliter) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  33. Change from Baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  34. Change from Baseline in Clinical chemistry parameters: Albumin and Total Protein (Grams per deciliter) [ Time Frame: Baseline (Day 1) and up to Week 52 ]
  35. Number of participants with maximum toxicity grades increase from Baseline in hematology and clinical chemistry [ Time Frame: Up to Week 52 ]

Secondary Outcome Measures :
  1. Dose proportionality of Cabotegravir based on AUC(0-inf) [ Time Frame: Up to Week 52 ]
  2. Dose proportionality of Cabotegravir based on AUC(0-t) [ Time Frame: Up to Week 52 ]
  3. Dose proportionality of Cabotegravir based on Cmax [ Time Frame: Up to Week 52 ]
  4. Dose proportionality of Cabotegravir based on plasma concentration [ Time Frame: Weeks 4, 8, 12 and 24 ]
  5. Number of participants with maximum post-baseline QTc values compared to baseline by category (to <=450 milliseconds (msec) or no change, to >450 msec to <=480 msec, to >480 msec to <=500 msec, and to >500 msec) [ Time Frame: Up to Week 52 ]
  6. Number of participants with maximum post-baseline increase in QTc values compared to baseline based on category (increase <=30 msec, increase of 31-60 msec, and increase of >60 msec) [ Time Frame: Up to Week 52 ]
  7. Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline for diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate [ Time Frame: Up to Week 52 ]
    Number of participants with worst case post-baseline values relative to potential clinical importance criteria compared to baseline will be categorized into change to low, change to within range or no change, and change to high.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At the time of obtaining informed consent, participants age should be equal to or greater than (=>)18 years and equal to or less than (=<) 55 years.
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • Body weight =>40 kilogram (kg) and body mass index (BMI) within the range =>18 to =<32 kilogram per meter square (kg/m^2).
  • Participants who are negative on a single test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction [PCR] laboratory or point of care test), performed on the day of admission. A negative result is required prior to the administration of study intervention on Day 1.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving written informed consent.

Exclusion Criteria:

  • Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities.
  • History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period.
  • Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms which in the opinion of the investigator are suggestive of coronavirus disease 2019 (COVID-19) (i.e., fever, cough etc) within 14 days of inpatient admission, or having contact with known COVID-19 positive person/s in the 14 days prior to inpatient admission.
  • Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test.
  • History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.
  • Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
  • Abnormal blood pressure.
  • Evidence of previous myocardial infarction.
  • Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular [AV] block [2nd degree or higher], Wolff- Parkinson-White [WPW] syndrome).
  • Any significant arrhythmia which, in the opinion of the investigator or the medical monitor, will interfere with the safety for the individual participant.
  • One or more exclusionary values for a screening Electrocardiogram (ECG).
  • Alanine transaminase (ALT) >1.5x upper limit of normal (ULN).
  • Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
  • Estimated Glomerular Filtration Rate (eGFR) <60 milliliter per minute (mL/min) using the Chronic Kidney Disease
  • Improved Prediction Equations (CKD-EPI) Creatinine Equation (2021).
  • Hemoglobin <12.5 gram per deciliter (g/dL) for men and <11 g/dL for women.
  • Positive pre-study drug/alcohol screen.
  • Regular use of tobacco- or nicotine-containing products within 3 months prior to screening; or urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g., nicotine patches or vaporizing devices).
  • Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of >14 units for males or >7 units for females.
  • Regular use of known drugs of abuse.
  • Concurrent participation in another clinical trial (except imaging trials); or has participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day in this study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.
  • Exposure to more than four (4) new chemical entities within 12 months prior to the first dosing day.
  • History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation, including a known hypersensitivity to hyaluronidases.
  • Current or anticipated need for chronic anti-coagulation therapy.
  • Hereditary coagulation and platelet disorders (e.g., hemophilia or Von Willebrand disease [VWD]).
  • Participant has a tattoo overlying the location of injection or an underlying skin disease or condition (e.g., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that, in the opinion of the investigator, may interfere with interpretation of injection site reactions or administration of study intervention.
  • Any other clinical condition, behavior or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.
  • Participant who in the investigator's judgment poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05418868


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Florida
GSK Investigational Site Recruiting
Orlando, Florida, United States, 32806
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: James Dale Taylor II         
United States, Nevada
GSK Investigational Site Recruiting
Las Vegas, Nevada, United States, 89113
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Darin Brimhall         
United States, New Jersey
GSK Investigational Site Recruiting
Berlin, New Jersey, United States, 08009
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Michael A Hassman         
United States, Texas
GSK Investigational Site Recruiting
Austin, Texas, United States, 78744
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Craig Boyle         
Sponsors and Collaborators
ViiV Healthcare
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare
More Information
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT05418868    
Other Study ID Numbers: 218012
First Posted: June 14, 2022    Key Record Dates
Last Update Posted: January 8, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
URL: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ViiV Healthcare:
Cabotegravir (CAB)
Long-Acting Injection
Pharmacokinetics
Safety
Tolerability
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Cabotegravir
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents