Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function

• Status: Completed
• Trial end date: 2017-10-25
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key Inclusion Criteria:

• Calculated body mass index from 18 to 40 kg/m^2

• Not pregnant

• Normal electrocardiogram

• Participants with impaired liver function must be sufficiently healthy based upon medical history and physical examination, vital signs, and screening laboratory evaluations.

Key Exclusion Criteria:

• Participation in another clinical study (current or within last 30 days)

• HIV, hepatitis B virus, or active hepatitis C virus infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.