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

NCT04472650 | Completed Phase 1 Results FDA Drug

• 1 other identifier: BGB-Sitravatinib-101
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 administration in healthy adults.

Conditions

Tumor

Outcome Measures

Primary Outcomes (7)

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

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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Number of Participants With Adverse Events

  Up to Week 8

Study Arms (2)

Dosing Sequence 1: Sitravatinib Free Base then Malate Salt

EXPERIMENTAL

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

Drug: Sitravatinib

Dosing Sequence 2: Sitravatinib Malate Salt then Free Base

EXPERIMENTAL

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

Drug: Sitravatinib

Interventions

Sitravatinib DRUG

Administered orally as a free base capsule

Dosing Sequence 1: Sitravatinib Free Base then Malate Salt; Dosing Sequence 2: Sitravatinib Malate Salt then Free Base

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Neoplasms

Interventions

sitravatinib

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Study Officials

• Study Director

  BeiGene

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 15, 2020
• Study Start: July 23, 2020
• Primary Completion: November 9, 2020
• Study Completion: November 9, 2020
• Last Updated: October 26, 2024
• Results First Posted: December 27, 2021

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)