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