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

BeiGene26 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tumor

Interventions

SitravatinibDRUG

Administered orally as a free base capsule

SitravatinibDRUG

Administered orally as a malate salt capsule

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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 Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product. 3.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.

Locations (1)

Linear Clinical Research

Nedlands, Western Australia, Australia