NCT04944771

Study to Assess the Effect of Food and Acid Reducing Agents on the Absorption of Capivasertib in Healthy Participants

An Open-label, Randomized, Crossover Study in Healthy Subjects to Evaluate the Effect of Food and Acid Reducing Agent(s) on the Pharmacokinetics of Capivasertib

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 58 Years
• Healthy volunteers: Accepted

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

Detailed description

Part 1 of the study will comprise: * A screening period of maximum 28 days. * Three treatment periods \[Treatment A: Single oral dose of capivasertib in overnight fasted state, Treatment B:Single oral dose of capivasertib in fed state (high-fat, high-calorie breakfast) and Treatment C:Twice daily oral doses of rabeprazole for 3 days and a single dose on Day 1, and a single oral dose of capivasertib in fasted conditions\] during which subjects will be resident from the morning of Day -1 (Day -4 for subjects receiving rabeprazole \[Treatment C\]) and discharged after the last pharmacokinetic (PK) sample collection, 48 hours after dosing of capivasertib of each treatment period. * A final visit 7 to 14 days after the last capivasertib PK sample in Treatment Period 3. Part 2 of the study will only be initiated if the findings from Part 1 show an interaction or are inconclusive. Part 2 of the study will comprise: * A screening period of at least 28 days. * Three treatment periods \[Any 3 treatments: Treatment D:Single oral dose of capivasertib in overnight fasted state, Treatment E: Single oral dose of capivasertib in fed state (low-fat, low-calorie breakfast), Treatment F: Single oral dose of capivasertib in partially fasted conditions (food restricted from 2 hours prior to dosing until 1 hour after dosing), Treatment G: Single oral dose of capivasertib and single dose of famotidine in fasted condition and Treatment H: Twice daily oral doses of rabeprazole for 3 days (Days -3 to -1) and a single oral dose of capivasertib in fed state\] during which subjects will be resident from the morning of Day -1 (Day -4 for subjects receiving rabeprazole \[Treatment H\]) and will be discharged after the last PK sample collection 48 hours after dosing of capivasertib of each treatment period. * A final visit 7 to 14 days after the last capivasertib PK sample in Treatment Period 3. The interim results from Part 1 indicated a potentially clinically relevant food interaction only and therefore Treatments D, E, and F will be studied in Part 2.

Conditions

• Solid and Hematological Malignancies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-26
• Primary completion: 2022-05-04
• Completion: 2022-05-04
• First posted: 2021-06-30
• Last updated: 2022-05-09

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study