At a glance
ClinicalIndex Comparison Record- ✓Chronic hepatic insufficiency lasting more than 6 months
- ✓Stable hepatic insufficiency with no acute episodes in the previous 2 months due to deterioration in hepatic function
- ✓Child-Pugh Score of 7 to 9 (moderate hepatic insufficiency)
- ✓Estimated creatinine clearance >60 mL/min or eGFR ≥60 mL/min/1.73 m²
- ✕History or presence of drug abuse within the past 2 years
- ✕History or presence of HIV
- ✕History or presence of hepatitis B virus (HBV) or hepatitis C virus (HCV)
- ✕History or presence of significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (other than hepatic impairment), endocrine, immunologic, dermatologic, or neurological disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-3102 in Patients With Impaired Hepatic Function
In Brief
A Phase 1 clinical trial evaluating MK-3102 for Diabetes Mellitus, Type 2. Completed, enrolled 16 participants.
Detailed Summary
This study will investigate and compare the pharmacokinetics of a single 25-mg dose of MK-3102 in participants with moderate hepatic impairment and matched healthy participants. The primary hypothesis is that in participants with moderately impaired hepatic function, the area under the concentration-time curve from time zero to infinity (AUC0-∞) is similar to that observed in healthy matched control participants following a single 25 mg oral dose of MK-3102. Specifically, the true ratio (moderately impaired hepatic function patients/healthy matched control subjects) of geometric means for AUC0-∞ is no greater than 2.
Study Details
Timeline
Interventions
Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.