A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investigate the Pharmacokinetics of Camizestrant When Administered Alone and in Combination With Carbamazepine in Healthy Post-Menopausal Female Participants

Sponsor
AstraZeneca
Study ID
NCT06547164
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Midazolam — DRUG
    Midazolam will be administered orally.
  • Camizestrant — DRUG
    Camizestrant will be administered orally.
  • Carbamazepine — DRUG
    Carbamazepine will be administered orally.

Study Details

This study will be conducted in order to determine the effect of repeated oral doses of camizestrant on the pharmacokinetics (PK) of midazolam and to determine the effect of repeated oral titrated doses of carbamazepine on the PK of camizestrant in healthy post-menopausal female participants.

Key Dates

First listed
Aug 9, 2024
Start date
Aug 27, 2024
Status verified
Aug 2025
Primary completion
Aug 20, 2025
Completion
Aug 20, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Midazolam + Camizestrant
    Participants will receive a single oral dose of midazolam on Day 1 in Period 1, followed by oral dose of camizestrant OD from Day 2 to Day 6 in Period 2, and then single oral dose of midazolam with camizestrant on Day 7 with PK sampling on Day 7 to Day 8 in Period 3.
  • Experimental: Part B: Camizestrant + Carbamazepine
    Participants will receive a single oral dose of camizestrant on Day 1 with PK sampling on Day 1 to Day 4 in Period 1, followed by low oral doses of carbamazepine BID on Day 4 to Day 6, mid oral doses of carbamazepine BID on Day 7 to Day 9 and high oral doses of carbamazepine BID on Day 10 to Day 15 with single oral dose of camizestrant on Day 13 with PK sampling on Day 16 in Period 2.

Primary Outcome Measure

Part A: Area under concentration-time curve from time 0 to infinity (AUCinf) of midazolam [ Time Frame: Period 1 (Day 1) and Period 3 (Day 7 to Day 8) ]

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