A Study of MK-0616 in Participants With Moderate Renal Impairment (MK-0616-007)

• Status: Not yet recruiting
• Trial end date: 2022-05-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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 ≥90 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