Clinical trial · Interventional
Study to Assess the Effect of Food and Acid Reducing Agents on the Absorption of Capivasertib in Healthy Participants
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
NCT04944771CI-TRIAL-00058352completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid and Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capivasertib | Drug | Capivasertib | ALIAS |
| Rabeprazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- Treatment ABC
- description
- Participants will be randomized to receive oral doses of Treatment A, Treatment B and Treatment C.
- interventionNames
- Drug: Capivasertib
- Drug: Rabeprazole
- type
- EXPERIMENTAL
- label
- Treatment ACB
- description
- Participants will be randomized to receive oral doses of Treatment A, Treatment C and Treatment B.
- interventionNames
- Drug: Capivasertib
- Drug: Rabeprazole
- type
- EXPERIMENTAL
- label
- Treatment BAC
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 58 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 1. 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. 2. 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. Exclusion Criteria: * 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: 1. Diagnosis of diabetes mellitus type I or II (irrespective of management). 2. Blood glucose value ≥ 5.9 mmol/L after fasting for at least 8 hours, at screening or on admission to study center. 3. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.