Spots Global Cancer Trial Database for A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body

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Trial Identification

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

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

Study ID: NCT04712396

Conditions

Healthy Volunteers (Intended Indication: Metastatic Patients With Triple Negative or HR+ Breast Cancer, or Hormone Sensitive Prostate Cancer)

Interventions

Capivasertib

Itraconazole

Study Description

Brief Summary: 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.

Detailed Description: 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.