A study to assess how Itraconazole affects the uptake and elimination of Capivasertib in the body

Study identifier:D3614C00004

ClinicalTrials.gov identifier:NCT04712396

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-label, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of Capivasertib When Administered Alone and In Combination with Itraconazole

Medical condition

Healthy volunteers (Intended Indication: Metastatic patients with triple negative or HR+ breast cancer, or hormone sensitive prostate cancer)

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Capivasertib, Itraconazole

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 58 Years

Date

Study Start Date: 01 Feb 2021

Primary Completion Date: 25 Mar 2021

Study Completion Date: 25 Mar 2021

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Mar 2022 by AstraZeneca

Collaborators

Parexel International

Inclusion and exclusion criteria

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 have a negative pregnancy test at screening and on admission to the study centre, 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 the Screening Visit), with documented post-procedural medical assessment of surgical success.
- Have a body mass index between 18 and 28 kg/m^2 inclusive 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 or the use of other nicotine/nicotine-containing products.

Exclusion Criteria

- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer’s ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs; abnormalities in haematology, clinical chemistry, or urinalysis results, at screening or on admission to the study centre, as judged by the Investigator.
- Any clinically significant abnormalities in glucose metabolism, blood lipid profiles , liver enzymes , vital signs , and 12-lead electrocardiogram.
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg) or antibody to hepatitis B core antigen (anti-HBc), hepatitis C antibody (anti-HCV), and human immunodeficiency virus (HIV) antibody.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator.
- Positive screen for drugs of abuse, alcohol and/or cotinine at screening or on admission to the study centre.
- Subjects who have previously received capivasertib.
- Subject has a positive test result for Severe acute respiratory syndrome (SARS)-Coronavirus (CoV)-2 Reverse Transcriptase (RT)-Polymerase Chain Reaction (PCR) before randomization.
- Subject has clinical signs and symptoms consistent with corona virus disease 2019 (COVID-19) (e.g., fever, dry cough, dyspnoea, 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.
- Subjects who are regularly exposed to the risk of COVID-19 infection as part of their daily life (e.g., health care professionals working in COVID-19 wards or at emergency departments).

No locations available

Arms	Assigned Interventions
Experimental: Capivasertib + Itraconazole Subjects will receive a single oral dose of capivasertib on Day 1 during treatment period 1, itraconazole on Days 3, 4, and 5 during treatment period 2, and single oral dose of capivasertib plus a dose of itraconazole on Day 6, followed by itraconazole alone on Day 7 during treatment period 3.	-

Documents available

redacted CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Rainard Fuhr

Parexel International GmbH