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NCT01980953 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Particle Size, Formulation and Food on the Pharmacokinetics of GDC-0032 in Healthy Volunteers
A Phase 1 study of Healthy Volunteer, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
- 1
- Study location
NCT01980953: Completed Phase 1 study of Healthy Volunteer, sponsored by Genentech.
NCT01980953 is a Phase 1 study of Healthy Volunteer that has completed, run by Genentech. The registered enrollment target is 76 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01980953, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
- 1
- Study location
Study Summary
This 4-part study will assess the effect of formulation, food, and active pharmaceutical ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period crossover studies. Participants will receive single doses of GDC-0032 capsule or tablet formulation, in the fasted or fed state.
Conditions Studied
Interventions
- DRUG GDC-0032 Phase III Tablet
- DRUG GDC-0032 Tablet
- DRUG GDC-0032 Capsule
Study Locations (1)
Texas
- Covance Research Unit - Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT01980953 record still lists
NCT01980953 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 3 interventions - of which GDC-0032 Phase III Tablet is the first listed.
NCT01980953 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01980953 about?
NCT01980953 is a clinical study titled "A Study to Evaluate the Effect of Particle Size, Formulation and Food on the Pharmacokinetics of GDC-0032 in Healthy Volunteers". This 4-part study will assess the effect of formulation, food, and active pharmaceutical ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period crossover studies. Participants ...
What is the current status of trial NCT01980953?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2013-11. Estimated completion is 2014-07.
What conditions does trial NCT01980953 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT01980953?
The interventions under investigation include: GDC-0032 Phase III Tablet (DRUG), GDC-0032 Tablet (DRUG), GDC-0032 Capsule (DRUG).
Who is sponsoring clinical trial NCT01980953?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01980953 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01980953's enrollment target sits among peer trials
76 46th of 112 higher than 67 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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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