Kidney function may change how this drug works – a trial investigates
NCT ID NCT05070390
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This early-phase study is testing how a single oral dose of the experimental drug MK-0616 (enlicitide chloride) is processed by the body in people with moderate kidney impairment compared to healthy volunteers. The goal is to measure drug levels in the blood over time and check safety and tolerability. The findings could help guide appropriate dosing for patients with reduced kidney function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- enlicitide chloride (MK-0616), an oral drug given as a 10 mg capsule
- What this could lead to
- If successful, this could help determine the right dosing of MK-0616 for people with moderate kidney impairment, potentially making the drug safer and more effective for them.
- What could go wrong
- This is a small, early-phase study focused on drug levels and safety, not on treating a disease. Results may not apply to people with more severe kidney problems, and the drug could still cause side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
18 people
The number who actually took part.
- Started
-
Nov 2021
- Finished
-
May 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Renal Impairment (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 Corona virus disease (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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alliance for Multispecialty Research, LLC ( Site 0001)
Knoxville, Tennessee, 37920, United States
-
Velocity Clinical Research, Hallandale Beach ( Site 0002)
Hallandale, Florida, 33009, United States
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