Solid and Hematological MalignanciesPhase 1NCT04944771

Study to Assess the Effect of Food and Acid Reducing Agents on the Absorption of Capivasertib in Healthy Participants

A Phase 1 study testing Capivasertib and Rabeprazole in people with Solid and Hematological Malignancies, 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

This is a two-part, open-label, randomized, crossover study in healthy subjects (vasectomized males and women of non-childbearing potential), performed at 2 study centers Read more about this study

Who is it for?: Ages 18 to 58 yearsHealthy volunteers can take part
Conditions the study is for: Solid and Hematological Malignancies
What is being tested?: Capivasertib and Rabeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteGermany
Study dates: 26 Jul 2021to 4 May 2022
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 58 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male and female subjects aged 18 to 58 years with suitable veins for cannulation or repeated venipuncture.
Females must not be lactating and must be of non-childbearing potential, confirmed at screening:
Postmenopausal defined as aged > 40 years and amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle stimulating hormone levels in the postmenopausal range.
Documentation of irreversible/permanent surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation, at least 6 months prior to screening.
Male subjects must be vasectomized, at least 6 months prior to screening, with documented post-procedural medical assessment of surgical success.
Have a body mass index between 18.0 and 29.9 kg/m^2 (inclusive) for males and 18 to 32 kg/m^2 (inclusive) for females; and weigh at least 50 kg and no more than 100 kg inclusive.
Non-smoker, defined as a subject who has not smoked previously or who has discontinued smoking.

Who cannot join

History of any clinically significant disease or disorder.
History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
Any clinically significant abnormal findings in vital signs at screening and/or admission to the study center.
Clinically significant abnormalities in glucose metabolism defined by any of the following:
Diagnosis of diabetes mellitus type I or II (irrespective of management).

Show all 19Show fewer

Blood glucose value ≥ 5.9 mmol/L after fasting for at least 8 hours, at screening or on admission to study center.
Glycosylated hemoglobin > upper limit of normal (up to 6.2% [44 mmol/mol]).
Any positive result on screening for serum hepatitis B surface antigen or antibody to hepatitis B core antigen, hepatitis C antibody, and human immunodeficiency virus antibody.
Known or suspected history of drug abuse.
Has received another new chemical entity within 3 months of the first administration of IMP in this study.
Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to capivasertib, rabeprazole, or famotidine.
Subjects who have previously received capivasertib.
Subject has a positive test result for Severe acute respiratory syndrome coronavirus 2 reverse transcription polymerase chain reaction on admission.
Subject has clinical signs and symptoms consistent with Coronavirus Disease 2019 (COVID-19) (eg, fever, dry cough, dyspnea, sore throat, anosmia/hyposmia, loss or reduced taste, and fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
History of severe COVID-19 (hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).
Subjects who are regularly exposed to the risk of COVID-19 infection as part of their daily life (eg, health care professionals working in COVID-19 wards or at emergency departments).
Subjects who have had a COVID-19 vaccine within 3 weeks prior to screening or are planning to get a COVID-19 vaccine during the study.

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, Randomized, Crossover Study in Healthy Subjects to Evaluate the Effect of Food and Acid Reducing Agent(s) on the Pharmacokinetics of Capivasertib

This is a two-part, open-label, randomized, crossover study in healthy subjects (vasectomized males and women of non-childbearing potential), performed at 2 study centers

Read the detailed description

Part 1 of the study will comprise:

A screening period of maximum 28 days.
Three treatment periods [Treatment A: Single oral dose of capivasertib in overnight fasted state, Treatment B:Single oral dose of capivasertib in fed state (high-fat, high-calorie breakfast) and Treatment C:Twice daily oral doses of rabeprazole for 3 days and a single dose on Day 1, and a single oral dose of capivasertib in fasted conditions] during which subjects will be resident from the morning of Day -1 (Day -4 for subjects receiving rabeprazole [Treatment C]) and discharged after the last pharmacokinetic (PK) sample collection, 48 hours after dosing of capivasertib of each treatment period.
A final visit 7 to 14 days after the last capivasertib PK sample in Treatment Period 3.

Part 2 of the study will only be initiated if the findings from Part 1 show an interaction or are inconclusive. Part 2 of the study will comprise:

A screening period of at least 28 days.
Three treatment periods [Any 3 treatments: Treatment D:Single oral dose of capivasertib in overnight fasted state, Treatment E: Single oral dose of capivasertib in fed state (low-fat, low-calorie breakfast), Treatment F: Single oral dose of capivasertib in partially fasted conditions (food restricted from 2 hours prior to dosing until 1 hour after dosing), Treatment G: Single oral dose of capivasertib and single dose of famotidine in fasted condition and Treatment H: Twice daily oral doses of rabeprazole for 3 days (Days -3 to -1) and a single oral dose of capivasertib in fed state] during which subjects will be resident from the morning of Day -1 (Day -4 for subjects receiving rabeprazole [Treatment H]) and will be discharged after the last PK sample collection 48 hours after dosing of capivasertib of each treatment period.
A final visit 7 to 14 days after the last capivasertib PK sample in Treatment Period 3.

The interim results from Part 1 indicated a potentially clinically relevant food interaction only and therefore Treatments D, E, and F will be studied in Part 2.

Conditions: Solid and Hematological Malignancies
Being tested: Capivasertib, Rabeprazole
Keywords: Crossover, Acid reducing agent, Food effect, Pharmacokinetics, Serine/threonine specific protein kinase inhibitor
Medical subject headings: Hematologic Neoplasms

What participants receive

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

CapivasertibDrug
Participants will receive single oral dose of capivasertib on Day 1 for Treatments A, B, C, D, E and F.
RabeprazoleDrug
Participants will receive twice daily oral doses of rabeprazole for 3 days (Days -3 to -1) and a single dose on the morning of Day 1 for Treatment C.

Study groups in NCT04944771
Study group	Role	What they receive
Treatment ABC	Experimental	Participants will be randomized to receive oral doses of Treatment A, Treatment B and Treatment C. Receives: Drug: Capivasertib; Drug: Rabeprazole
Treatment ACB	Experimental	Participants will be randomized to receive oral doses of Treatment A, Treatment C and Treatment B. Receives: Drug: Capivasertib; Drug: Rabeprazole
Treatment BAC	Experimental	Participants will be randomized to receive oral doses of Treatment B, Treatment A and Treatment C. Receives: Drug: Capivasertib; Drug: Rabeprazole
Treatment BCA	Experimental	Participants will be randomized to receive oral doses of Treatment B, Treatment C and Treatment A. Receives: Drug: Capivasertib; Drug: Rabeprazole
Treatment CAB	Experimental	Participants will be randomized to receive oral doses of Treatment C, Treatment A and Treatment B. Receives: Drug: Capivasertib; Drug: Rabeprazole
Treatment CBA	Experimental	Participants will be randomized to receive oral doses of Treatment C, Treatment B and Treatment A. Receives: Drug: Capivasertib; Drug: Rabeprazole
Treatment DEF	Experimental	Participants will be randomized to receive oral doses of Treatment D, Treatment E and Treatment F. Receives: Drug: Capivasertib
Treatment DFE	Experimental	Participants will be randomized to receive oral doses of Treatment D, Treatment F and Treatment E. Receives: Drug: Capivasertib
Treatment EDF	Experimental	Participants will be randomized to receive oral doses of Treatment E, Treatment D and Treatment F. Receives: Drug: Capivasertib
Treatment EFD	Experimental	Participants will be randomized to receive oral doses of Treatment E, Treatment F and Treatment D. Receives: Drug: Capivasertib
Treatment FDE	Experimental	Participants will be randomized to receive oral doses of Treatment F, Treatment D and Treatment E. Receives: Drug: Capivasertib
Treatment FED	Experimental	Participants will be randomized to receive oral doses of Treatment F, Treatment E and Treatment D. Receives: Drug: Capivasertib

What is being measured

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

Cmax of Capivasertib
Maximum observed plasma (peak) drug concentration (Cmax) of capivasertib when administered alone under fed and fasted conditions, and in combination with acid reducing agent(s) rabeprazole and famotidine (if required).
Measured: Part 1 and Part 2: From Day 1 to Day 3
AUCinf of Capivasertib
Area under plasma concentration time curve from zero to infinity (AUCinf) of capivasertib when administered alone under fed and fasted conditions, and in combination with acid reducing agent(s) rabeprazole and famotidine (if required).
Measured: Part 1 and Part 2: From Day 1 to Day 3
AUClast of Capivasertib
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of capivasertib when administered alone under fed and fasted conditions, and in combination with acid reducing agent(s) rabeprazole and famotidine (if required).
Measured: Part 1 and Part 2: From Day 1 to Day 3

Secondary outcomes (1)

Number of participants with serious and non-serious adverse events
Safety and tolerability of capivasertib when administered alone under fed and fasted conditions, and in combination with acid reducing agent(s) rabeprazole and famotidine (if required).
Measured: Part 1: From Screening (Day -28 to Day -5) upto Follow-up Visit/Early Termination (7 to 14 days); Part 2: From Screening (Day -28 to Day -2) upto Follow-up Visit/Early Termination (7 to 14 days)

Timeline

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

26 Jul 20214 May 2022

First posted30 Jun 2021
Study start26 Jul 2021
Primary completion4 May 2022
Study completion4 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid and Hematological MalignanciesStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04944771
Sponsor's protocol ID: D3614C00005
Other IDs: 2021-000836-74
Status last verified: May 2022
First submitted: 28 Jun 2021
Last updated: 9 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
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. 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Crossover Study in Healthy Subjects to Evaluate the Effect of Food and Acid Reducing Agent(s) on the Pharmacokinetics of Capivasertib
ClinicalTrials.gov ID: NCT04944771
Acronym / sponsor ID: D3614C00005
Conditions: Solid and Hematological Malignancies
Keywords: Crossover, Acid reducing agent, Food effect, Pharmacokinetics, Serine/threonine specific protein kinase inhibitor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 26 Jul 2021 (actual)
Primary completion: 4 May 2022 (actual)
Study completion: 4 May 2022 (actual)
First posted: 30 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a two-part, open-label, randomized, crossover study in healthy subjects (vasectomized males and women of non-childbearing potential), performed at 2 study centers

Detailed description

Part 1 of the study will comprise:

A screening period of maximum 28 days.
Three treatment periods [Treatment A: Single oral dose of capivasertib in overnight fasted state, Treatment B:Single oral dose of capivasertib in fed state (high-fat, high-calorie breakfast) and Treatment C:Twice daily oral doses of rabeprazole for 3 days and a single dose on Day 1, and a single oral dose of capivasertib in fasted conditions] during which subjects will be resident from the morning of Day -1 (Day -4 for subjects receiving rabeprazole [Treatment C]) and discharged after the last pharmacokinetic (PK) sample collection, 48 hours after dosing of capivasertib of each treatment period.
A final visit 7 to 14 days after the last capivasertib PK sample in Treatment Period 3.

Part 2 of the study will only be initiated if the findings from Part 1 show an interaction or are inconclusive. Part 2 of the study will comprise:

A screening period of at least 28 days.
Three treatment periods [Any 3 treatments: Treatment D:Single oral dose of capivasertib in overnight fasted state, Treatment E: Single oral dose of capivasertib in fed state (low-fat, low-calorie breakfast), Treatment F: Single oral dose of capivasertib in partially fasted conditions (food restricted from 2 hours prior to dosing until 1 hour after dosing), Treatment G: Single oral dose of capivasertib and single dose of famotidine in fasted condition and Treatment H: Twice daily oral doses of rabeprazole for 3 days (Days -3 to -1) and a single oral dose of capivasertib in fed state] during which subjects will be resident from the morning of Day -1 (Day -4 for subjects receiving rabeprazole [Treatment H]) and will be discharged after the last PK sample collection 48 hours after dosing of capivasertib of each treatment period.
A final visit 7 to 14 days after the last capivasertib PK sample in Treatment Period 3.

The interim results from Part 1 indicated a potentially clinically relevant food interaction only and therefore Treatments D, E, and F will be studied in Part 2.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
Treatment ABC	Experimental	Drug: Capivasertib, Drug: RabeprazoleParticipants will be randomized to receive oral doses of Treatment A, Treatment B and Treatment C.
Treatment ACB	Experimental	Drug: Capivasertib, Drug: RabeprazoleParticipants will be randomized to receive oral doses of Treatment A, Treatment C and Treatment B.
Treatment BAC	Experimental	Drug: Capivasertib, Drug: RabeprazoleParticipants will be randomized to receive oral doses of Treatment B, Treatment A and Treatment C.
Treatment BCA	Experimental	Drug: Capivasertib, Drug: RabeprazoleParticipants will be randomized to receive oral doses of Treatment B, Treatment C and Treatment A.
Treatment CAB	Experimental	Drug: Capivasertib, Drug: RabeprazoleParticipants will be randomized to receive oral doses of Treatment C, Treatment A and Treatment B.
Treatment CBA	Experimental	Drug: Capivasertib, Drug: RabeprazoleParticipants will be randomized to receive oral doses of Treatment C, Treatment B and Treatment A.
Treatment DEF	Experimental	Drug: CapivasertibParticipants will be randomized to receive oral doses of Treatment D, Treatment E and Treatment F.
Treatment DFE	Experimental	Drug: CapivasertibParticipants will be randomized to receive oral doses of Treatment D, Treatment F and Treatment E.
Treatment EDF	Experimental	Drug: CapivasertibParticipants will be randomized to receive oral doses of Treatment E, Treatment D and Treatment F.
Treatment EFD	Experimental	Drug: CapivasertibParticipants will be randomized to receive oral doses of Treatment E, Treatment F and Treatment D.
Treatment FDE	Experimental	Drug: CapivasertibParticipants will be randomized to receive oral doses of Treatment F, Treatment D and Treatment E.
Treatment FED	Experimental	Drug: CapivasertibParticipants will be randomized to receive oral doses of Treatment F, Treatment E and Treatment D.

Who may qualify

Ages: 18 to 58 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male and female subjects aged 18 to 58 years with suitable veins for cannulation or repeated venipuncture.
Females must not be lactating and must be of non-childbearing potential, confirmed at screening:
Male subjects must be vasectomized, at least 6 months prior to screening, with documented post-procedural medical assessment of surgical success.
Have a body mass index between 18.0 and 29.9 kg/m^2 (inclusive) for males and 18 to 32 kg/m^2 (inclusive) for females; and weigh at least 50 kg and no more than 100 kg inclusive.

Key exclusion criteria (19 listed)

History of any clinically significant disease or disorder.
History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
Any clinically significant abnormal findings in vital signs at screening and/or admission to the study center.
Clinically significant abnormalities in glucose metabolism defined by any of the following:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CapivasertibParticipants will receive single oral dose of capivasertib on Day 1 for Treatments A, B, C, D, E and F.	Drug	Treatment ABC, Treatment ACB, Treatment BAC, Treatment BCA, Treatment CAB, Treatment CBA, Treatment DEF, Treatment DFE, Treatment EDF, Treatment EFD, Treatment FDE, Treatment FED
RabeprazoleParticipants will receive twice daily oral doses of rabeprazole for 3 days (Days -3 to -1) and a single dose on the morning of Day 1 for Treatment C.	Drug	Treatment ABC, Treatment ACB, Treatment BAC, Treatment BCA, Treatment CAB, Treatment CBA

Primary outcome

Cmax of Capivasertib
Time frame: Part 1 and Part 2: From Day 1 to Day 3
Maximum observed plasma (peak) drug concentration (Cmax) of capivasertib when administered alone under fed and fasted conditions, and in combination with acid reducing agent(s) rabeprazole and famotidine (if required).
AUCinf of Capivasertib
Time frame: Part 1 and Part 2: From Day 1 to Day 3
Area under plasma concentration time curve from zero to infinity (AUCinf) of capivasertib when administered alone under fed and fasted conditions, and in combination with acid reducing agent(s) rabeprazole and famotidine (if required).
AUClast of Capivasertib
Time frame: Part 1 and Part 2: From Day 1 to Day 3
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of capivasertib when administered alone under fed and fasted conditions, and in combination with acid reducing agent(s) rabeprazole and famotidine (if required).

1 secondary outcome

Number of participants with serious and non-serious adverse events
Time frame: Part 1: From Screening (Day -28 to Day -5) upto Follow-up Visit/Early Termination (7 to 14 days); Part 2: From Screening (Day -28 to Day -2) upto Follow-up Visit/Early Termination (7 to 14 days)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. 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.

Related trials for Solid and Hematological Malignancies

Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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Active, not recruitingPhase 2
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Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Capivasertib and Rabeprazole in people with Solid and Hematological Malignancies, 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?

The sponsor lists 8 inclusion and 19 exclusion criteria. 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 9 May 2022. 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?

Cmax of Capivasertib (time frame: Part 1 and Part 2: From Day 1 to Day 3). 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 NCT04944771.

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 9 May 2022.