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

NCT ID: NCT07241065

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-28
• Study Completion Date: 2027-12-03

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dextromethorphan/ Dextromethorphan + Capivasertib

Participants will receive a single dose of dextromethorphan in Period 1. After a minimum washout period of 4 days from the first dose of dextromethorphan, participants will receive the first dose of capivasertib, followed by a second dose of capivasertib after 12 hours, administered concomitantly with a single dose of dextromethorphan in Period 2.

Group Type: EXPERIMENTAL

Dextromethorphan

Intervention Type: DRUG

Dextromethorphan will be administered orally once in Period 1 and once in Period 2

Capivasertib

Intervention Type: DRUG

Capivasertib will be administered orally twice in Period 2

Interventions

Dextromethorphan

Dextromethorphan will be administered orally once in Period 1 and once in Period 2

Intervention Type: DRUG

Capivasertib

Capivasertib will be administered orally twice in Period 2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have a Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
• All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
• Females of non-childbearing potential must be confirmed at the screening visit (postmenopausal or documentation of irreversible surgical sterilisation).
• Male participants must have documentation of vasectomy done 6 months prior to screening visit. Participants must be willing to use one barrier method of contraception (condom) during sexual intercourse with a female partner of childbearing potential from the time of first study intervention administration until 16 weeks after the last dose of capivasertib.

Exclusion Criteria

• History of any clinically important disease or disorder
• History or presence of gastrointestinal, hepatic or renal disease.
• Any clinically important illness, medical/surgical procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first administration of study intervention or an anticipated need for major surgery during the study.
• Any clinically significant skin abnormalities that are chronic or currently active.
• Abnormal hepato-renal and bone marrow organ function laboratory values.
• Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis.
• Any clinically significant abnormalities in glucose metabolism.
• Any positive result on screening for serum HBsAg OR anti-HBc antibody, indicative of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
• Current smokers or those who have smoked or used other nicotine/nicotine-containing products within the previous 3 months prior to Screening Visit.
• Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
• Use of drugs with enzyme inducing properties 3 weeks prior to the first administration of study intervention.
• Use of strong inhibitors of Cytochrome P450 3A4 (CYP3A4) or strong/moderate inducers of CYP3A4 within 2 weeks prior to first dose of capivasertib.
• Concurrent use of herbal or natural products intended as treatment or prophylaxis that may interact with capivasertib.
• Participants who have previously received capivasertib.
• Any clinically significant abnormal findings in vital signs and 12-lead electrocardiogram (ECG).
• History of severe allergy/hypersensitivity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

AstraZeneca Clinical Study Information Center

Role: CONTACT

information.center@astrazeneca.com

1-877-240-9479

Other Identifiers

D3615C00005

Identifier Type: -

Identifier Source: org_study_id