NCT04935112

A Study to Explore the Effect of Acid-reducing Agents

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Mirati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-07-07
• Primary completion: 2021-08-12
• Completion: 2022-07-12
• First posted: 2021-06-22
• Last updated: 2022-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study