Actively Recruiting
A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants
Led by AstraZeneca · Updated on 2026-04-15
42
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess the effect of capivasertib on the pharmacokinetics of oral dextromethorphan in healthy participants.
CONDITIONS
Official Title
A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged between 18 and 60 years
- Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg
- Female participants must have a negative pregnancy test at screening and on admission
- Females of non-childbearing potential confirmed by postmenopausal status or surgical sterilisation documentation
- Male participants must have had vasectomy at least 6 months before screening and agree to use a condom during sexual intercourse with partners of childbearing potential from first drug dose until 16 weeks after last capivasertib dose
You will not qualify if you...
- History of any significant disease or disorder
- History or presence of gastrointestinal, liver, or kidney disease
- Any significant illness, medical/surgical procedure (except vascular access), or major trauma within 4 weeks before first study drug dose
- Chronic or active significant skin abnormalities
- Abnormal liver, kidney, or bone marrow lab test results
- Significant abnormalities in clinical chemistry, blood, urine tests, or glucose metabolism
- Positive test for hepatitis B, hepatitis C, or HIV
- Current smokers or nicotine product users within 3 months before screening
- History or suspicion of alcohol or drug abuse or excessive alcohol intake
- Use of enzyme-inducing drugs within 3 weeks before first study drug dose
- Use of strong CYP3A4 inhibitors or inducers within 2 weeks before first capivasertib dose
- Concurrent use of herbal or natural products that might interact with capivasertib
- Previous treatment with capivasertib
- Significant abnormalities in vital signs or ECG
- History of severe allergy or hypersensitivity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site
Berlin, Germany, 14050
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
1
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