Study to Assess the Effect of Food and Acid Reducing Agents on the Absorption of Capivasertib in Healthy Participants
NCT04944771 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2022-05-09
Summary
This is a two-part, open-label, randomized, crossover study in healthy subjects (vasectomized males and women of non-childbearing potential), performed at 2 study centers
Conditions
- Solid and Hematological Malignancies
Interventions
- DRUG
-
Capivasertib
Participants will receive single oral dose of capivasertib on Day 1 for Treatments A, B, C, D, E and F.
- DRUG
-
Rabeprazole
Participants will receive twice daily oral doses of rabeprazole for 3 days (Days -3 to -1) and a single dose on the morning of Day 1 for Treatment C.
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 58 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-07-26
- Primary Completion
- 2022-05-04
- Completion
- 2022-05-04
- FDA Drug
- Yes
Countries
- Germany
Study Locations
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