A Phase 1, Open-label, Single-dose, Parallel-group Study Evaluating the Pharmacokinetics of Oral Repinatrabit (JNT-517) Immediate Release Tablet in Hepatic or Renal Impaired Adult Participants Matched to Adult Participants With Normal Hepatic and Renal Function

Otsuka Pharmaceutical Development & Commercialization, Inc.

Summary

This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have normal liver function.

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion criteria: 1. Body mass index (BMI) from 18.0 to 38.0 kilograms per square meter (kg/m\^2) (inclusive). 2. Able to provide written, informed consent. 3. Male participants and female participants of childbearing potential (POCBP) must agree to remain fully abstinent from intercourse where pregnancy can occur OR practice 2 different contraceptive methods, where at least one must be highly effective. 4. Otherwise be in generally good health. 5. Additional criteria for Group 1: i. Have moderate hepatic impairment determined using Child-Pugh classification (Class B). ii. Have rela…

Interventions

Drug
Repinatrabit
Oral tablet

Location

Panax Clinical Research
Miami, Florida

A Phase 1, Open-label, Single-dose, Parallel-group Study Evaluating the Pharmacokinetics of Oral Repinatrabit (JNT-517) Immediate Release Tablet in Hepatic or Renal Impaired Adult Participants Matched to Adult Participants With Normal Hepatic and Renal Function

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions