Clinical trial NCT04472650: Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumor
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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 Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.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

Primary outcomes:
measure: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib
timeFrame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
measure: Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-t) of Sitravatinib
timeFrame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
measure: Maximum Observed Plasma Concentration (Cmax) of Sitravatinib
timeFrame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
measure: Time of the Maximum Observed Plasma Concentration (Tmax) of Sitravatinib
timeFrame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
measure: Apparent Terminal Elimination Half-life (T1/2) of Sitravatinib
timeFrame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
measure: Apparent Total Plasma Clearance (CL/F) of Sitravatinib
timeFrame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
measure: Apparent Volume of Distribution (Vz/F) of Sitravatinib
timeFrame: Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours postdose in each study period
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to Week 8
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
affiliation: BeiGene
name: Study Director
role: PRINCIPAL_INVESTIGATOR
References: