Clinical trial · Interventional
Relative Bioavailability of Two Different Capsule Formulations of Sitravatinib in Healthy Adults
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
NCT04472650CI-TRIAL-00081941completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sitravatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dosing Sequence 1: Sitravatinib Free Base then Malate Salt
- description
- 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
- interventionNames
- Drug: Sitravatinib
- type
- EXPERIMENTAL
- label
- Dosing Sequence 2: Sitravatinib Malate Salt then Free Base
- description
- 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
- interventionNames
- Drug: Sitravatinib
Primary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.