A Phase 1, Single-Dose, Open-Label Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on Aleniglipron Pharmacokinetics
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Summary
The purpose of this study is to evaluate the PK of aleniglipron in participants with Hepatic Impairment to establish scientifically guided dosing recommendations in these special patient populations.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Is an adult, male or female, ≥ 18 to 85 years of age (inclusive), at screening. 2. Female and male participants must follow protocol-specified contraception guidance as described in Section 5.4.2.1 and Section 5.4.2.2. 3. Is a continuous non-smoker or smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing. Participants must agree to maintain the same smoking status (i.e., smoker or non-smoker) from screening and until after the last PK sample collection. 4. BMI ≥ 17.0 and ≤ 40.0 kg/m2 and weight of at least 40.0 kg at screening. 5. Understa…
Interventions
- DrugAleniglipron
administered orally
Locations (2)
- Research SiteOrlando, Florida
- Research SiteSan Antonio, Texas