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

BeiGene

Status and phase: Completed; Phase 1

Conditions: Tumor

Treatments: Drug: Sitravatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04472650

BGB-Sitravatinib-101

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Dosing Sequence 1: Sitravatinib Free Base then Malate Salt

Experimental group

Description:

Sitravatinib free base capsule 120 mg on Day 1 in Period 1 then sitravatinib malate salt capsule 100 mg on Day 1 in Period 2, with a minimum washout period between dose administrations of 14 days

Treatment:

Drug: Sitravatinib

Drug: Sitravatinib

Dosing Sequence 2: Sitravatinib Malate Salt then Free Base

Experimental group

Description:

Sitravatinib malate salt capsule 100 mg on Day 1 in Period 1 then sitravatinib free base capsule 120 mg on Day 1 in Period 2, with a minimum washout period between dose administrations of 14 days

Treatment:

Drug: Sitravatinib

Drug: Sitravatinib