Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01980953
The ClinicalTrials.gov registry entry for NCT01980953 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (62% lower). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Healthy Volunteer Study
RECRUITING · Phase 1
-
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
RECRUITING · Phase 1
-
Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors
RECRUITING · Phase 1
-
A First-in-Human Single and Multiple Ascending Dose Study of MT-201
RECRUITING · Phase 1
-
A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants
RECRUITING · Phase 1
-
A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.