NCT07088913

A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants

An Open-label, Fixed-sequence Study to Assess the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin (a BCRP, OATP1B1 and OATP1B3 Sensitive Substrate) in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the effect of capivasertib on the pharmacokinetics (PK) of oral rosuvastatin in healthy participants.

Detailed description

This study is an open-label, fixed-sequence, drug-drug interaction study of orally administered rosuvastatin in the presence and absence of capivasertib in healthy participants. The study will comprise: 1. A Screening Period of maximum 28 days. 2. Two Treatment Periods * Period 1: Participants will receive single oral dose of rosuvastatin. * Period 2: Participants will receive two single oral doses of capivasertib administered 12 hours apart, with the first capivasertib dose being concomitantly administered with a single oral dose of rosuvastatin. 3. A final Follow-up Visit within 7 to 10 days after the last study intervention administration. There will be a minimum washout period of at least 7 days between the first dose of rosuvastatin (in Treatment Period 1) and the second dose of rosuvastatin (in Treatment Period 2).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Capivasertib	Capivasertib will be administered orally twice in Period 2.
DRUG	Rosuvastatin	Rosuvastatin will be administered orally once in both Period 1 and Period 2.

Timeline

• Start date: 2025-07-28
• Primary completion: 2026-02-20
• Completion: 2026-02-20
• First posted: 2025-07-28
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study