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Trial record 1 of 6 for:    MK-0616
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MK-0616 (Oral PCSK9 Inhibitor) Renal Impairment Study 2 (MK-0616-020)

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ClinicalTrials.gov Identifier: NCT05934292
Recruitment Status : Completed
First Posted : July 6, 2023
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
The primary objective of the study is to compare the plasma pharmacokinetics (PK) of MK-0616 following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment (moderate, severe, end stage renal disease [ESRD]) to those of healthy mean matched control participants on a background of statin therapy. There is no formal hypothesis.

Condition or disease Intervention/treatment Phase
Hypercholesterolaemia Drug: MK-0616 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-0616 in Participants With Varying Degrees of Renal Impairment
Actual Study Start Date : July 20, 2023
Actual Primary Completion Date : January 19, 2024
Actual Study Completion Date : January 19, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Panel A: Moderate Renal Impairment (RI)
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days)
 Drug: MK-0616
Single oral dose
Experimental: Panel B: Severe RI
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days)
 Drug: MK-0616
Single oral dose
Experimental: Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days). Period 2 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 2 = 15 days). A washout period of 14 days will separate Period 1 and Period 2.
 Drug: MK-0616
Single oral dose
Experimental: Panel D: Healthy
Period 1 Day 1: Participants receive MK-0616 20 mg tablet single dose orally (Period 1 = 15 days)
 Drug: MK-0616
Single oral dose


Outcome Measures
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Primary Outcome Measures :
  1. Panels A, B, and D: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-0616: Period 1 [ Time Frame: Period 1: Predose and 0.5, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose (Period 1 = 15 days) ]
    Blood for plasma samples will be collected at pre-specified timepoints to determine the AUC0-inf of MK-0616

  2. Panel C: AUC0-inf of MK-0616: Periods 1 and 2 [ Time Frame: Periods 1 and 2: Predose and 0.5, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose (each period = 15 days) ]
    Blood for plasma samples will be collected at pre-specified timepoints to determine the AUC0-inf of MK-0616

  3. Panels A, B and D: AUC from Time 0 to Last Measurable Concentration (AUClast) of MK-0616: Period 1 [ Time Frame: Period 1: Predose and 0.5, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose (Period 1 = 15 days) ]
    Blood for plasma samples will be collected at pre-specified timepoints to determine the AUClast of MK-0616

  4. Panel C: AUClast of MK-0616: Periods 1 and 2 [ Time Frame: Periods 1 and 2: Predose and 0.5, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose (each period = 15 days ]
    Blood for plasma samples will be collected at pre-specified timepoints to determine the AUClast of MK-0616

  5. Panels A, B and D: Maximum Plasma Concentration (Cmax) of MK-0616: Period 1 [ Time Frame: Period 1: Predose and 0.5, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 postdose (Period 1 = 15 days) ]
    Blood for plasma samples will be collected at pre-specified time points to determine the Cmax of MK-0616

  6. Panel C: Maximum Plasma Concentration (Cmax) of MK-0616: Periods 1 and 2 [ Time Frame: Periods 1 and 2: Predose and 0.5, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose (each period = 15 days ]
    Blood for plasma samples will be collected at pre-specified time points to determine the Cmax of MK-0616

  7. Panel A, B, and D: Time to Maximum Plasma Concentration (Tmax) of MK-0616: Period 1 [ Time Frame: Period 1: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the Tmax of MK-0616

  8. Panel C: Time to Maximum Plasma Concentration (Tmax) of MK-0616: Periods 1 and 2 [ Time Frame: Periods 1 and 2: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the Tmax of MK-0616

  9. Panels A, B and D: Apparent Terminal Half-life (t1/2) of MK-0616: Period 1 [ Time Frame: Period 1: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the t1/2 of MK-0616

  10. Panel C: t1/2 of MK-0616: Periods 1 and 2 [ Time Frame: Periods 1 and 2: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the t1/2 of MK-0616

  11. Panel A, B and D: Apparent Clearance (CL/F) of MK-0616: Period 1 [ Time Frame: Period 1: Predose and 0.5, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose (Period 1 = 15 days) ]
    Blood for plasma samples will be collected at pre-specified time points to determine the CL/F of MK-0616

  12. Panel C: Apparent Clearance (CL/F) of MK-0616: Periods 1 and 2 [ Time Frame: Periods 1 and 2: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the CL/F of MK-0616

  13. Panels A, B and D: Apparent Volume of Distribution (Vz/F) of MK-0616 [ Time Frame: Period 1: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the Vz/F of MK-0616

  14. Panel C: Apparent Volume of Distribution (Vz/F) of MK-0616 [ Time Frame: Periods 1 and 2: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168 and 240 hours postdose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the Vz/F of MK-0616


Secondary Outcome Measures :
  1. Dialysate Clearance (CLd) of MK-0616 [ Time Frame: Predose and up to 8 hours postdose- Panel C (Period 2) ]
    CLd is the amount of MK-0616 cleared from plasma via dialysis.

  2. Dialysate Concentration of MK-0616 [ Time Frame: Predose and up to 8 hours postdose- Panel C (Period 2) ]
    Cd is the concentration of MK-0616 in dialysate.

  3. Amount of MK-0616 Excreted (AEd) in Dialysate [ Time Frame: Predose and up to 8 hours postdose- Panel C (Period 2) ]
    The amount of MK-0616 excreted in the dialysate will be assessed.

  4. Percentage of Dose (%Dose) of MK-0616 Excreted in Dialysate [ Time Frame: Predose and up to 8 hours postdose- Panel C (Period 2) ]
    The percentage of the dose of MK-0616 in the dialysate will be assessed.

  5. Amount of MK-0616 Excreted in Urine from 0 to 24 hours (AE0-24) [ Time Frame: Predose and up to 24 hours postdose (All Panels: Period 1; Panel C: Period 2) ]
    The amount of MK-0616 excreted in urine in first 24 hours after dosing will be reported.

  6. Fraction of Unchanged MK-0616 Excreted in Urine (Fe) [ Time Frame: Predose and up to 24 hours postdose (All Panels: Period 1; Panel C: Period 2) ]
    The fraction of unchanged MK-0616 excreted in urine will be reported

  7. Renal Clearance (CLr) of MK-0616 [ Time Frame: Predose and up to 24 hours postdose (All Panels: Period 1; Panel C: Period 2) ]
    The CLr of MK-0616 will be reported

  8. Percentage of Participants Who Experience at Least 1 Adverse Event (AE) [ Time Frame: Up to approximately 30 days ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention

  9. Percentage of Participants Who Discontinue From the Study due to an AE [ Time Frame: Up to approximately 30 days ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be in good health with the exception of renal impairment (RI) and hypercholesterolemia for participants in Panels A, B, and C. Participants with RI that have stable, chronic medical or psychiatric conditions, including but not limited to hypertension, hypercholesterolemia, diabetes mellitus, hyper- or hypothyroidism, gout, and chronic anxiety or depression may be included at the discretion of the investigator.
  • Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 40 kg/m2, inclusive
  • Be on a stable dose of any statin therapy defined as: no changes to dose or type of statin therapy for at least 2 months prior to Screening and participant anticipates no changes to statin therapy throughout the study until the poststudy visit

Exclusion Criteria:

  • History or presence of renal artery stenosis.
  • Had a functioning renal transplant in the past 5 years and is taking transplant medication.
  • Participants in panels A, B and D: Has rapidly fluctuating renal function as determined by historical measurements
  • Has a history gastrointestinal disease which might affect food and drug absorption, as determined by the investigator, or has had gastric bypass or similar surgery
  • History of cancer (malignancy)
  • History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
  • Has received an anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) small molecule treatment, monoclonal antibody, or short interfering RNA (siRNA) or RNA interference (ie, Inclisiran) within 12 months prior to Screening
  • Participants with RI (Panels A, B, and C): Taking medications to treat chronic medical conditions and/or conditions associated with renal disease, if participant has not been on a stable regimen for at least 1 month (other than statins, which require a stable dose for at least 2 months) prior to administration of the initial dose of study intervention, and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 4 hours after administration of study intervention
  • Participated in another investigational study within 4 weeks prior to the prestudy (screening) visit
  • Consumes greater than 3 servings of alcoholic beverages per day
  • Consumes excessive amounts, defined as greater than 6 servings of caffeinated beverages per day
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): NCT05934292


Locations
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United States, Florida
Velocity Clinical Research, Hallandale Beach ( Site 0003)
Hallandale Beach, Florida, United States, 33009
Clinical Pharmacology of Miami ( Site 0005)
Miami, Florida, United States, 33014-3616
Advanced Pharma CR, LLC ( Site 0001)
Miami, Florida, United States, 33147
Orlando Clinical Research Center ( Site 0004)
Orlando, Florida, United States, 32809
Genesis Clinical Research, LLC ( Site 0002)
Tampa, Florida, United States, 33603
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05934292    
Other Study ID Numbers: 0616-020
MK-0616-020 ( Other Identifier: Merck )
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases