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MK-0616 for Kidney Disease

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI) ≥18 kg/m^2 and ≤40 kg/m^2.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours post dose
Awards & highlights

Study Summary

This trial is testing a drug in people with moderate kidney impairment to see how it affects the drug's pharmacokinetics compared to healthy people.

Eligible Conditions
  • Moderate Kidney Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your body mass index (BMI) falls between 18 and 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, 168, 240, and 336 hours post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC from Time 0 to Last Measurable Concentration (AUClast) of MK-0616
Apparent Clearance (CL/F) of MK-0616
Apparent Terminal Half-life (t1/2) of MK-0616
+4 more
Secondary outcome measures
Amount Recovered in Urine from 0 to 24 hours (Ae0-24) of MK-0616
Fraction of Dose Recovered in Urine (Fe) of MK-0616
Maximum Percent Change in Free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) from Baseline
+3 more

Side effects data

From 2022 Phase 2 trial • 381 Patients • NCT05261126
7%
COVID-19
5%
Nausea
4%
Diarrhoea
4%
Dyspepsia
1%
Arthralgia
1%
Fatigue
1%
Acute left ventricular failure
1%
Road traffic accident
1%
Respiratory distress
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-0616 18 mg
MK-0616 30 mg
MK-0616 6 mg
Placebo
MK-0616 12 mg

Trial Design

2Treatment groups
Experimental Treatment
Group I: Panel B- Healthy ControlsExperimental Treatment1 Intervention
Single dose of MK-0616 10 mg
Group II: Panel A- Moderate RIExperimental Treatment1 Intervention
Single dose of MK-0616 10 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-0616
2023
Completed Phase 2
~440

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,893 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,860 Previous Clinical Trials
5,047,836 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,766 Previous Clinical Trials
8,060,775 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment available to seniors aged 60 and over?

"The age range for successful applicants in this trial is 18 to 75 years old. There are 6 studies dedicated to minors and 158 specialized trials focusing on individuals over the age of 65."

Answered by AI

How many participants are taking part in this experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this experiment is presently recruiting trialists, with the initial post being issued on November 16th 2021 and recently modified on October 11th 2022. 18 volunteers are needed to be sourced from two separate locations."

Answered by AI

What are the anticipated results of this experiment?

"According to the information provided by Merck Sharp & Dohme LLC, who sponsor this study, they will be gauging Time to Maximum Plasma Concentration (Tmax) of MK-0616 from pre-dose and post dose measurements within a 0 - 336 hour timeframe. Additionally, secondary objectives include evaluating Amount Recovered in Urine from 0 to 24 hours (Ae0-24), maximum percent change in free Proprotein Convertase Subtilisin Kexin 9 (PCSK9) compared with baseline following administration of a single dose of MK-0616, and counting the number of participants that discontinue due to an"

Answered by AI

Am I eligible to enroll in this clinical research endeavor?

"This clinical study is in need of 18 participants who are suffering from renal failure, with ages ranging between 18 and 75 years old. To be eligible for the trial, applicants must have passed medical history and physical examinations, possess vital signs within normal ranges, receive a passing score on laboratory safety tests including ECG's; BMI should fall between 18-40 kg/m^2; male candidates must either practice abstinence or use protective measures during intercourse throughout the course of treatment; female patients must be non-childbearing potential; moderate RI participants should present an eGFR ≥30 mL/min/1.73 m^2 at baseline that"

Answered by AI

Is enrolment in this research study still available for participants?

"According to information on clinicaltrials.gov, the medical trial is actively seeking participants and was first made public on November 16th 2021 with a subsequent update occurring October 11th 2022."

Answered by AI

Has the FDA issued approval of MK-0616?

"As MK-0616 is in its early stages of development, the limited amount of clinical data available has resulted in a score of 1 to reflect its safety."

Answered by AI
~5 spots leftby Mar 2025