Phase 1
Completed N=16
A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013)
Source: ClinicalTrials.gov NCT01737684 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Area Under the Concentration Time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg — 4.10; 3.23 uM•hr
Summary
This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618) administered to participants with moderate hepatic insufficiency and healthy participants matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild hepatic insufficiency.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration Time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg |
4.10; 3.23 | — |
| SECONDARY Apparent Clearance (CL/F), Calculated as Dose/AUC0-∞, After a Single Oral Dose of Vibegron 100 mg |
56.0; 68.3 | — |
| SECONDARY Apparent Volume of Distribution During the Terminal Phase (Vd/F) After a Single Oral Dose of Vibegron 100 mg |
7640; 9120 | — |
| SECONDARY Maximum Observed Plasma Drug Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg |
378; 281 | — |
| SECONDARY Time to Maximum Observed Plasma Drug Concentration (Tmax) After a Single Oral Dose of Vibegron 100 mg |
1.00; 1.50 | — |
| SECONDARY Apparent Terminal Half-life (t½) After a Single Oral Dose of Vibegron 100 mg |
94.54; 92.48 | — |
Eligibility Criteria
Inclusion Criteria
For both healthy participants and participants with hepatic insufficiency:
- Continuous non-smokers who haven't used nicotine-containing products for at least 3 months prior to study drug administration
- Body mass index (BMI) ≤39 kg/m^2
- Good health based on medical history, physical examination, vital signs, laboratory safety tests, and electrocardiogram (ECG)
- Females of childbearing potential must be sexually inactive for 14 days prior to study drug administration and throughout study or use acceptable birth control method
- Females of non-childbearing potential must have undergone an acceptable sterilization procedure at least 6 months prior to Day 1 of study or be postmenopausal with amenorrhea for at least 1 year prior to Day 1
- Non-vasectomized males must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 3 months after study drug administration
For participants with hepatic insufficiency only:
- Diagnosis of chronic, stable, hepatic insufficiency
- For Part 1 Participants: Child-Pugh scale range from 7 to 9
- For Part 2 Participants: Child-Pugh scale range from 5 to 6
Data sourced from ClinicalTrials.gov (NCT01737684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.