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Healthy ParticipantsPhase 1NCT07241065

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

A Phase 1 study testing Dextromethorphan and Capivasertib in people with Healthy Participants, run by AstraZeneca at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Dextromethorphan and Capivasertib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteGermany
Study dates
19 Mar 2026to 20 Jul 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Research Site

    Berlin, 14050

Other trials in Germany

About this study

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

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).
Being tested
Dextromethorphan, Capivasertib
Keywords
Serine/protein kinase AKT, Anti-cancer agent, Pharmacokinetics, Protein kinase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DextromethorphanDrug

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

  • CapivasertibDrug

    Capivasertib will be administered orally twice in Period 2

Study groups in NCT07241065
Study groupRoleWhat they receive
Dextromethorphan/ Dextromethorphan + CapivasertibExperimentalParticipants 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.
Receives: Drug: Dextromethorphan; Drug: Capivasertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8

Secondary outcomes (18)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Period 1: Day 1 to Day 3

  8. Terminal rate constant (λz) of dextromethorphan

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Period 1: Day 1 to Day 2, Period 2: Day 4 to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2025
  2. Study start19 Mar 2026
  3. Primary completion20 Jul 2026
  4. Study completion20 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07241065
Sponsor's protocol ID
D3615C00005
Status last verified
Jul 2026
First submitted
17 Nov 2025
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dextromethorphan and Capivasertib in people with Healthy Participants, run by AstraZeneca at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under concentration time curve from time 0 to infinity (AUCinf) of dextromethorphan (time frame: Period 1: Day 1 to Day 3, Period 2: Day 6 to Day 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07241065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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