Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults

• Status: Completed
• Trial end date: 2020-11-09
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of the study is to investigate the relative bioavailability and pharmacokinetics (PK) of sitravatinib free base and malate salt capsule formulations following oral administration in healthy adults.

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

Details

• Lead Sponsor: BeiGene

Criteria

Key Inclusion Criteria:

1. Body mass index between 18.0 and 32.0 kg/m2, inclusive.

2. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).

3. Are able to swallow multiple capsules.

Key Exclusion Criteria:

1. History of stomach or intestinal surgery or resection

2. Have previously completed or withdrawn from this study or any other study investigating sitravatinib, and have previously received the investigational product.

3. Participants who, in the opinion of the Investigator (or designee), should not participate in this study.

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