Status:

COMPLETED

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

Lead Sponsor:

BeiGene

Conditions:

Tumor

Eligibility:

MALE

18-55 years

Phase:

PHASE1

Brief Summary

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 administratio...

Eligibility Criteria

Inclusion

  • Key
  • Body mass index between 18.0 and 32.0 kg/m2, inclusive.
  • 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).
  • Able to swallow multiple capsules.
  • Key

Exclusion

  • History of stomach or intestinal surgery or resection
  • Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.
  • 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.

Key Trial Info

Start Date :

July 23 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 9 2020

Estimated Enrollment :

26 Patients enrolled

Trial Details

Trial ID

NCT04472650

Start Date

July 23 2020

End Date

November 9 2020

Last Update

October 26 2024

Active Locations (1)

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1

Linear Clinical Research

Nedlands, Western Australia, Australia, 6009