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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04472650




Registration number
NCT04472650
Ethics application status
Date submitted
14/07/2020
Date registered
15/07/2020
Date last updated
27/12/2021

Titles & IDs
Public title
Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults
Scientific 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
Secondary ID [1] 0 0
BGB-Sitravatinib-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sitravatinib
Treatment: Drugs - Sitravatinib

Experimental: Dosing Sequence 1: Sitravatinib Free Base then Malate Salt - 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

Experimental: Dosing Sequence 2: Sitravatinib Malate Salt then Free Base - 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: Drugs: Sitravatinib
Administered orally as a free base capsule

Treatment: Drugs: Sitravatinib
Administered orally as a malate salt capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-8) of Sitravatinib
Timepoint [1] 0 0
Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary outcome [2] 0 0
Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-t) of Sitravatinib
Timepoint [2] 0 0
Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary outcome [3] 0 0
Maximum Observed Plasma Concentration (Cmax) of Sitravatinib
Timepoint [3] 0 0
Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary outcome [4] 0 0
Time of the Maximum Observed Plasma Concentration (Tmax) of Sitravatinib
Timepoint [4] 0 0
Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary outcome [5] 0 0
Apparent Terminal Elimination Half-life (T1/2) of Sitravatinib
Timepoint [5] 0 0
Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary outcome [6] 0 0
Apparent Total Plasma Clearance (CL/F) of Sitravatinib
Timepoint [6] 0 0
Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Primary outcome [7] 0 0
Apparent Volume of Distribution (Vz/F) of Sitravatinib
Timepoint [7] 0 0
Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Secondary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
Up to Week 8

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/11/2020
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research Pty Lt(LCR) - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04472650
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04472650