A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole

Sponsor
AstraZeneca
Study ID
NCT05551897
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Camizestrant — DRUG
    Subjects will be administered a single oral dose of Camizestrant on Day 1 of treatment period 1 and treatment period 3.
  • Itraconazole — DRUG
    Subjects will be administered Itraconazole twice a day on Day 1 and once daily on Day 2 and Day 3 of treatment period 2, and once daily on Day 1, 2 and 3 of treatment period 3.

Study Details

This study will be conducted in healthy post-menopausal female subjects to assess the pharmacokinetics (PK) of Camizestrant (AZD9833) when administered alone and in combination with Itraconazole.

Key Dates

Start date
Oct 4, 2022
Status verified
Jan 2023
Primary completion
Dec 28, 2022
Completion
Dec 28, 2022

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Treatment Arm
    Subjects will receive a single oral dose of Camizestrant on Day 1 of treatment period 1. Following washout period of 7 to 10 days, subjects will receive Itraconazole on Days 1, 2, and 3 of treatment period 2, and single oral dose of Camizestrant plus a dose of Itraconazole on Day 1, followed by Itraconazole alone on Day 2 and Day 3 of treatment period 3.

Primary Outcome Measure

Area under plasma concentration time curve from zero to infinity (AUCinf) of Camizestrant [ Time Frame: Day 1 to Day 4 (Period 1 and Period 3) ]

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