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.
- Moderate Kidney Disease
7 Primary · 6 Secondary · Reporting Duration: 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
2 Treatment Groups
Panel B- Healthy Controls
1 of 2
Panel A- Moderate RI
1 of 2
18 Total Participants · 2 Treatment Groups
Primary Treatment: MK-0616 · No Placebo Group · Phase 1
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Age 18 - 75 · All Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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" - Anonymous Online Contributor
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" - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor