Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects

Part of paid clinical trials in San Antonio, Texas.

Sponsor
AstraZeneca
Study ID
NCT05790304
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Camizestrant — DRUG
    Camizestrant 75 mg tablets. Experimental drug.

Study Details

This will be a Phase I, multicentre, single-dose, non-randomized, open-label, parallel-group study to examine the PK, safety, and tolerability of camizestrant 75 mg in post-menopausal female participants with moderate or severe hepatic impairment compared with post-menopausal female participants with normal hepatic function. Participants will be enrolled within the following groups based on their CP classification score as determined at screening: * Group 1: Matched-control healthy participants with normal hepatic function. * Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). * Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).

Key Dates

Start date
Feb 20, 2023
Status verified
Mar 2025
Primary completion
Feb 22, 2024
Completion
Feb 22, 2024

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Group 1
    Matched-control healthy participants with normal hepatic function.
  • Other: Group 2
    Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
  • Other: Group 3
    Participants with severe hepatic impairment (CP Class C, score of 10 to 15).

Primary Outcome Measure

PK parameters Cmax [ Time Frame: 5 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteSan AntonioTexas78215-
Research SiteSan AntonioTexas78229-

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Research Site· San Antonio, TX

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