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

Tumor Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04472650
• Other study ID #: BGB-Sitravatinib-101
• Status: Completed
• Phase: Phase 1
• Start date: July 23, 2020
• Est. completion date: November 9, 2020

Study information

• Verified date: November 2021
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 administration in healthy adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 9, 2020
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.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

Related Conditions & MeSH terms

• Tumor

Intervention

Drug:
• Sitravatinib
Administered orally as a free base capsule
• Sitravatinib
Administered orally as a malate salt capsule

Locations

Country	Name	City	State
Australia	Linear Clinical Research Pty Lt(LCR)	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-8) of Sitravatinib		Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary	Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-t) of Sitravatinib		Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary	Maximum Observed Plasma Concentration (Cmax) of Sitravatinib		Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary	Time of the Maximum Observed Plasma Concentration (Tmax) of Sitravatinib		Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary	Apparent Terminal Elimination Half-life (T1/2) of Sitravatinib		Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary	Apparent Total Plasma Clearance (CL/F) of Sitravatinib		Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary	Apparent Volume of Distribution (Vz/F) of Sitravatinib		Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Secondary	Number of Participants With Adverse Events	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	Up to Week 8