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NCT05790304 · ClinicalTrials.gov registry record · Phase 1
Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT05790304 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 22 participants.
The verdict
NCT05790304, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Camizestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-02-20 |
| Est. Completion | 2024-02-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05790304
The ClinicalTrials.gov registry entry for NCT05790304 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Camizestrant is the first listed.
NCT05790304 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05790304 about?
NCT05790304 is a clinical study titled "Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects". 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 wit...
What is the current status of trial NCT05790304?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2023-02-20. Estimated completion is 2024-02-22.
What interventions are being tested in trial NCT05790304?
The interventions under investigation include: Camizestrant (DRUG).
Who is sponsoring clinical trial NCT05790304?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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