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Completed

NCT Number: NCT04472650

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

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.

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Key information

Conditions

Tumor Neoplasms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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 Criteria:

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  • Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.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

Treatment and study plan

Sitravatinib

Drug

Administered orally as a free base capsule

Primary outcomes

  1. Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period

  2. Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-t) of Sitravatinib

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period

  3. Maximum Observed Plasma Concentration (Cmax) of Sitravatinib

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period

  4. Time of the Maximum Observed Plasma Concentration (Tmax) of Sitravatinib

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period

  5. Apparent Terminal Elimination Half-life (T1/2) of Sitravatinib

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period

  6. Apparent Total Plasma Clearance (CL/F) of Sitravatinib

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period

  7. Apparent Volume of Distribution (Vz/F) of Sitravatinib

    Time frame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Up to Week 8

    Adverse events (AEs) and serious adverse events are defined as an AE that starts during or after the first dose, or starts prior to the first dose and increases in severity after the first dose, including vital signs, physical examination, electrocardiogram, and laboratory parameters

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

A Phase 1, Open-label, Single-dose, Randomized Crossover Study to Evaluate the Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 15, 2020
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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