Phase 1
Completed N=26
Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults
Source: ClinicalTrials.gov NCT04472650 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib — 2524.7; 2892.6 h*ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) of Sitravatinib |
2524.7; 2892.6 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-t) of Sitravatinib |
2458.4; 2821.8 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Sitravatinib |
54.96; 62.40 | — |
| PRIMARY Time of the Maximum Observed Plasma Concentration (Tmax) of Sitravatinib |
8.000; 8.000 | — |
| PRIMARY Apparent Terminal Elimination Half-life (T1/2) of Sitravatinib |
30.850; 28.490 | — |
| PRIMARY Apparent Total Plasma Clearance (CL/F) of Sitravatinib |
39.61; 41.48 | — |
| PRIMARY Apparent Volume of Distribution (Vz/F) of Sitravatinib |
1733.8; 1780.6 | — |
| SECONDARY Number of Participants With Adverse Events |
10; 8; 0; 0; 0; 0 | — |
Eligibility Criteria
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- Have previously completed or withdrawn from this study or any other study investigating sitravatinib and have previously received the investigational product.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.
Data sourced from ClinicalTrials.gov (NCT04472650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.