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CompletedNCT07241065Updated Jul 27, 2026

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

A Phase 1 interventional study of Dextromethorphan and Capivasertib in Healthy Participants, sponsored by AstraZeneca. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by AstraZeneca · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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).
02

Conditions studied

  • Healthy Participants

Keywords

  • Serine/protein kinase AKT
  • Anti-cancer agent
  • Pharmacokinetics
  • Protein kinase
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Dextromethorphan · Drug: Capivasertib

Interventions

  • DrugDextromethorphan

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

  • DrugCapivasertib

    Capivasertib will be administered orally twice in Period 2

06

What researchers measure

Primary outcomes

  1. Area under concentration time curve from time 0 to infinity (AUCinf) of dextromethorphan

    To evaluate the PK (AUCinf) of dextromethorphan when administered orally alone and following oral dosing of capivasertib

    Time frame: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8

  2. Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) of dextromethorphan

    To evaluate the PK (AUClast) of dextromethorphan when administered orally alone and following oral dosing of capivasertib

    Time frame: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8

  3. Maximum observed drug concentration (Cmax) of dextromethorphan

    To evaluate the PK (Cmax) of dextromethorphan when administered orally alone and following oral dosing of capivasertib

    Time frame: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8

Secondary outcomes

  1. Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) of capivasertib

    To evaluate the PK (AUClast) of capivasertib following oral dosing

    Time frame: Period 2: Day 5 to Day 8

  2. Time to reach maximum observed concentration (tmax) of capivasertib

    To evaluate the PK (tmax) of capivasertib following oral dosing

    Time frame: Period 2: Day 5 to Day 8

  3. Maximum observed drug concentration (Cmax) of capivasertib

    To evaluate the PK (Cmax) of capivasertib following oral dosing

    Time frame: Period 2: Day 5 to Day 8

  4. Ratio of AUCinf following co-administration to AUCinf following dosing alone (R AUCinf) of dextromethorphan

    To evaluate the PK (R AUCinf) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8

  5. Ratio of AUClast following co-administration to AUClast following dosing alone (R AUClast) of dextromethorphan

    To evaluate the PK (R AUClast) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8

  6. Ratio of Cmax following co-administration to Cmax following dosing alone (R Cmax) of dextromethorphan

    To evaluate the PK (R Cmax) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8

  7. Terminal elimination half-life (t1/2λz) of dextromethorphan

    To evaluate the PK (t1/2λz) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3

  8. Terminal rate constant (λz) of dextromethorphan

    To evaluate the PK (λz) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3

  9. Time to reach maximum observed concentration (tmax) of dextromethorphan

    To evaluate the PK (tmax) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3

  10. Area under concentration time curve from time 0 to infinity (AUCinf) of metabolite (dextrorphan)

    To evaluate the PK (AUCinf) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3

  11. Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) of metabolite (dextrorphan)

    To evaluate the PK (AUClast) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3

  12. Maximum observed drug concentration (Cmax) of metabolite (dextrorphan)

    To evaluate the PK (Cmax) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3

  13. Ratio of AUClast following co-administration to AUClast following dosing alone (R AUClast) of metabolite (dextrorphan)

    To evaluate the PK (R AUClast) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8

  14. Terminal elimination half-life (t1/2λz) of metabolite (dextrorphan)

    To evaluate the PK (t1/2λz) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3

  15. Terminal rate constant (λz) of metabolite (dextrorphan)

    To evaluate the PK (λz) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3

  16. Time to reach maximum observed concentration (tmax) of metabolite (dextrorphan)

    To evaluate the PK (tmax) of dextromethorphan following oral dosing

    Time frame: Period 1: Day 1 to Day 3

  17. Number of participants with adverse events (AEs) and serious AEs

    To examine the safety and tolerability of capivasertib when administered with dextromethorphan

    Time frame: Up to Day 16

  18. Percentage change from baseline in bilirubin levels

    To evaluate the effect of capivasertib dosing on total, conjugated, and unconjugated bilirubin levels

    Time frame: Period 1: Day 1 to Day 2, Period 2: Day 4 to Day 7

07

Study locations

1 site
  • Research Site
    Berlin, 14050, Germany
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07241065
Lead sponsor
AstraZeneca
Collaborators
Parexel
Responsible party
Sponsor
First posted
Nov 21, 2025
Start date
Mar 19, 2026
Primary completion
Jul 20, 2026
Completion
Jul 20, 2026
Last update
Jul 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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