A Study to Explore the Effect of Acid-reducing Agents
NCT04935112 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2022-08-26
Summary
A Phase 1 Study of the Effect of Acid-reducing Agents on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects. The study is a single-center, open-label, 2-period, 2-treatment, fixed-sequence crossover, parallel-group study.
Conditions
- Healthy Adults
Interventions
- DRUG
-
Sitravatinib
100 mg sitravatinib on Day 1
- DRUG
-
Pantoprazole
40 mg QD on Day 1 to Day 7 of Period 2 in Group 1
- DRUG
-
Famotidine
40 mg PO 2 hrs after sitravatinib in Period 2 of Group 2
Sponsors & Collaborators
-
Mirati Therapeutics Inc.
lead INDUSTRY
Principal Investigators
-
Curtis Chin, MD · Mirati Therapeutics Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-07
- Primary Completion
- 2021-08-12
- Completion
- 2022-07-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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