NCT07241065

A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants

An Open-label, Fixed-sequence Study to Assess the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effect of capivasertib on the pharmacokinetics of oral dextromethorphan in healthy participants.

Detailed description

This is an open-label, fixed sequence study conducted at a single study centre. The study will comprise of: * A Screening Period (from Day -28 to Day -2) * In-house treatment period (from Day -1 to Day 8) Period 1 (from Day -1 to Day 3): Participants will receive single oral doses of dextromethorphan during this period. Period 2 (from Day 4 to Day 8): Participants will receive 2 doses of capivasertib and a single dose of dextromethorphan during this period. • Follow-up Visit within 7 to 10 days after the last administration of the Investigative Medical Products (from Day 13 to Day 16).

Conditions

• Healthy Participants

Interventions

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

Timeline

• Start date: 2026-03-19
• Primary completion: 2026-06-17
• Completion: 2026-06-17
• First posted: 2025-11-21
• Last updated: 2026-04-15

Locations

1 site across 1 country: Germany