Evaluating MK-1084 in patients with kidney issues
A Clinical Study to Evaluate the Effect of Renal Impairment on the Single-Dose Pharmacokinetics of MK-1084
PHASE1 · Merck Sharp & Dohme LLC · NCT06814119
This study is testing how a new drug called MK-1084 is handled by the body in people with kidney problems compared to healthy individuals to see if it's safe for them.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC (industry) |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT06814119 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess how MK-1084 is processed in individuals with moderate to severe renal impairment compared to healthy participants. Researchers will monitor the levels of MK-1084 in the body over time and evaluate its safety and tolerability in those with renal impairment. The study focuses on understanding the pharmacokinetics of MK-1084 in a population that may metabolize the drug differently due to kidney function. Participants will be closely monitored to ensure their renal function is stable prior to dosing.
Who should consider this trial
Good fit: Ideal candidates include individuals with moderate to severe renal impairment who are otherwise healthy and have stable renal function.
Not a fit: Patients with a history of cancer or significant liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safe use of MK-1084 for patients with renal impairment, potentially leading to better treatment options.
How similar studies have performed: Other studies have explored drug metabolism in renal impairment, but this specific approach to MK-1084 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: All participants: - Has a BMI ≥18.0 and ≤40.0 kg/m\^2 Participants with severe or moderate RI: * With the exception of RI, is sufficiently healthy for study participation * Has stable renal function with no clinically significant change in renal status at least 29 days prior to dosing and is not currently or has not been previously on dialysis for at least 1 year Participants with normal renal function: - Is medically healthy Exclusion Criteria: The main exclusion criteria include but are not limited to the following: All participants: * Has a history of cancer (malignancy) * Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus * Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing Participants with severe or moderate RI: * Has a history or presence of renal artery stenosis * Has a renal transplant or nephrectomy
Where this trial is running
Orlando, Florida
- Orlando Clinical Research Center ( Site 0002) — Orlando, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy, Renal Impairment