Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Immune System Diseases

Prostatic Neoplasms

Breast Neoplasms

Hypersensitivity

Anti-Infective Agents

All Drugs and Chemicals

Itraconazole

Hydroxyitraconazole

Protein Kinase Inhibitors

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

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.

Subects will be administered single doses of capiversatib on Day 1 and Day 6.

Capivasertib

Subjects will be administered itraconazole twice daily on Day 3, followed by once daily doses in the morning for 4 days.

Rainard Fuhr, Dr.

This study will be an open-label, fixed sequence study in healthy subjects (vasectomized males and females of non-childbearing potential), performed at a single study centre.

The study will comprise:

* A screening period of maximum 21 days;
* A fixed sequence of 3 treatment periods: Treatment Period 1: Capivasertib only, Treatment Period 2: Itraconazole pre-treatment (run-in) period, and Treatment Period 3: Capivasertib and itraconazole in combination.
* A Follow-up Visit at 7 to 14 days after the last capivasertib PK sample in Treatment Period 3.

There will be no washout between Treatment Period 2 and Treatment Period 3. Each subject will be involved in the study for up to 7 weeks.

A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body

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

Assessment of AUClast of capivasertib and its major metabolite (AZ14102143).

Assessment of tmax of capivasertib and its major metabolite (AZ14102143).

Assessment of t½λz of capivasertib and its major metabolite (AZ14102143).

Assessment of λz of capivasertib and its major metabolite (AZ14102143).

Assessment of AUCinf of major metabolite (AZ14102143) of capivasertib.

Assessment of Cmax of major metabolite (AZ14102143) of capivasertib.

Assessment of safety and tolerability of capivasertib alone and in combination with itraconazole.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body	NCT04712396	Healthy Volunte...	Capivasertib Itraconazole	18 Years - 58 Years	AstraZeneca
A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body	NCT04712396	Healthy Volunte...	Capivasertib Itraconazole	18 Years - 58 Years	AstraZeneca

Spots Global Cancer Trial Database for healthy volunteers (intended indication: metastatic patients with triple negative or hr+ breast cancer, or hormone sensitive prostate cancer)