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Trial record 2 of 6 for:    MK-0616
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A Study of MK-0616 in Participants With Moderate Renal Impairment (MK-0616-007)

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ClinicalTrials.gov Identifier: NCT05070390
Recruitment Status : Completed
First Posted : October 7, 2021
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
This purpose of this study is to compare the pharmacokinetics (PK) of a single dose of MK-0616 in participants with moderate renal impairment (RI) to those of healthy matched control participants. This study is being conducted to assess the impact of moderate renal insufficiency on the PK of MK-0616.

Condition or disease Intervention/treatment Phase
Moderate Renal Impairment Drug: MK-0616 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Clinical Study to Evaluate the Pharmacokinetics of MK-0616 Following Administration of a Single Dose to Participants With Moderate Renal Impairment
Actual Study Start Date : November 16, 2021
Actual Primary Completion Date : May 3, 2023
Actual Study Completion Date : May 3, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Panel A- Moderate RI
Single dose of MK-0616 10 mg
 Drug: MK-0616
10 mg capsule administered orally
Experimental: Panel B- Healthy Controls
Single dose of MK-0616 10 mg
 Drug: MK-0616
10 mg capsule administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-0616 [ Time Frame: Pre-dose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours post dose ]
    Blood for plasma samples will be collected at pre-specified timepoints to determine the AUC0-inf of MK-0616

  2. AUC from Time 0 to Last Measurable Concentration (AUClast) of MK-0616 [ Time Frame: Pre-dose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours post dose ]
    Blood for plasma samples will be collected at pre-specified timepoints to determine the AUClast of MK-0616

  3. Maximum Plasma Concentration (Cmax) of MK-0616 [ Time Frame: Pre-dose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours post dose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the Cmax of MK-0616

  4. Time to Maximum Plasma Concentration (Tmax) of MK-0616 [ Time Frame: Pre-dose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours post dose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the Tmax of MK-0616

  5. Apparent Terminal Half-life (t1/2) of MK-0616 [ Time Frame: Pre-dose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours post dose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the t1/2 of MK-0616

  6. Apparent Clearance (CL/F) of MK-0616 [ Time Frame: Pre-dose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours post dose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the CL/F of MK-0616

  7. Apparent Volume of Distribution (Vz/F) of MK-0616 [ Time Frame: Pre-dose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours post dose ]
    Blood for plasma samples will be collected at pre-specified time points to determine the Vz/F of MK-0616


Secondary Outcome Measures :
  1. Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to approximately 14 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

  2. Number of Participants Who Discontinue From the Study due to an AE [ Time Frame: Up to approximately 14 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

  3. Amount Recovered in Urine from 0 to 24 hours (Ae0-24) of MK-0616 [ Time Frame: Pre-dose and and at 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post dose ]
    Urine will be collected at pre-specified time points to determine the Ae0-24 of MK-0616

  4. Fraction of Dose Recovered in Urine (Fe) of MK-0616 [ Time Frame: Pre-dose and and at 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post dose ]
    Urine will be collected at pre-specified time points to determine the Fe of MK-0616

  5. Renal Clearance (CLr) of MK-0616 [ Time Frame: Pre-dose and and at 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post dose ]
    Urine will be collected at pre-specified time points to determine the CLr of MK-0616

  6. Maximum Percent Change in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) from Baseline [ Time Frame: Baseline and up to 336 hours post dose ]
    Blood will be collected at pre-specified time points to determine the maximum percent change in free PCSK9 from baseline following administration of a single dose of MK-0616


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good health based upon medical history, physical examination, vital signs, laboratory safety tests, and electrocardiograms (ECG) performed before randomization.
  • Body mass index (BMI) ≥18 kg/m^2 and ≤40 kg/m^2.
  • Male participants must agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm, PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent, or use acceptable contraception per study protocol.
  • Female participants must be of non-childbearing potential.
  • Moderate RI participants: Baseline estimated glomerular filtration rate (eGFR) ≥30 and <60 mL/min/1.73 m^2 based on the Modification of Diet in Renal Disease (MDRD) equation.
  • Moderate RI participants: No clinically significant change in renal status at least 1 month prior to dosing and not currently receiving or has not previously been on hemodialysis.
  • Healthy Matched Controls: eGFR ≥80 mL/min/1.73 m^2 based on the MDRD equation.

Exclusion Criteria:

  • Healthy Matched Controls: history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
  • Mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator.
  • History of cancer, with the exception of adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study.
  • History of significant multiple and/or severe allergies.
  • Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
  • History of major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
  • Moderate RI participants: Does not agree to follow the smoking restrictions as defined by the study.
  • Healthy Matched Controls: History of smoking and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 3 months of screening.
  • Received any nonlive vaccine starting from 14 days prior to study intervention or is scheduled to receive any nonlive vaccine through 30 days following study intervention with the exception of COVID-19 vaccine administration. Study intervention must be given at least 72 hours following or at least 48 hours prior to any COVID-19 vaccination.
  • Consumes greater than 3 servings of alcoholic beverages per day.
  • Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
  • Regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months
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): NCT05070390


Locations
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United States, Florida
Velocity Clinical Research, Hallandale Beach ( Site 0002)
Hallandale Beach, Florida, United States, 33009
United States, Tennessee
Alliance for Multispecialty Research, LLC ( Site 0001)
Knoxville, Tennessee, United States, 37920
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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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05070390    
Other Study ID Numbers: 0616-007
MK-0616-007 ( Other Identifier: Merck )
First Posted: October 7, 2021    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023
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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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases