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NCT04274075 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Relative Bioavailability and Food Effect of GDC-9545 in Healthy Females of Non-Childbearing Potential
A Phase 1 study of Healthy Volunteers, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04274075: Completed Phase 1 study of Healthy Volunteers, sponsored by Genentech.
NCT04274075 is a Phase 1 study of Healthy Volunteers that has completed, run by Genentech. The registered enrollment target is 18 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04274075, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will be an open-label, randomized, three-period, six-sequence crossover study of GDC-9545 administered to healthy females of non-childbearing potential to determine the relative bioavailability of the Phase 3 capsule formulation to the Phase 1 tablet formulation in the fasted state and the effect of food on the Phase 3 capsule formulation.
Primary Outcome
The pharmacokinetics (PK) parameters were determined where possible from the plasma concentrations of GDC-9545 using non-compartmental methods performed using Phoenix WinNonlin. The PK parameters Cmax, AUC0-t, and AUC0-∞ for GDC-9545 were analyzed to evaluate the relative bioavailability of GDC-9545 as a Phase 3 capsule formulation compared to a Phase 1 tablet formulation under fasted conditions (Treatment B vs. Treatment A) and to assess the food effect on GDC-9545 PK for a Phase 3 capsule form
Conditions Studied
Interventions
- DRUG GDC-9545 Tablet, Fasted: Treatment A
- DRUG GDC-9545 Capsule, Fasted: Treatment B
- DRUG GDC-9545 Capsule, Fed: Treatment C
Study Locations (1)
Florida
- Covance Research Unit - Daytona - Daytona Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-03-06 |
| Est. Completion | 2020-04-16 |
| Phase | Phase 1 |
What the finished NCT04274075 record still lists
NCT04274075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which GDC-9545 Tablet, Fasted: Treatment A is the first listed.
NCT04274075 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04274075 about?
NCT04274075 is a clinical study titled "Evaluation of the Relative Bioavailability and Food Effect of GDC-9545 in Healthy Females of Non-Childbearing Potential". This study will be an open-label, randomized, three-period, six-sequence crossover study of GDC-9545 administered to healthy females of non-childbearing potential to determine the relative bioavailability of the Phase 3 capsule formulation to the Phase 1 tablet formulation in the fasted state and th...
What is the current status of trial NCT04274075?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-03-06. Estimated completion is 2020-04-16.
What conditions does trial NCT04274075 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04274075?
The interventions under investigation include: GDC-9545 Tablet, Fasted: Treatment A (DRUG), GDC-9545 Capsule, Fasted: Treatment B (DRUG), GDC-9545 Capsule, Fed: Treatment C (DRUG).
Who is sponsoring clinical trial NCT04274075?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04274075 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04274075's enrollment target sits among peer trials
18 229th of 283 higher than 50 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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