NCT01980953 is a Phase 1 clinical trial of GDC-0032 Phase III Tablet in Healthy Volunteer, sponsored by Genentech, Inc..

Who is sponsoring NCT01980953?

NCT01980953 is sponsored by Genentech, Inc..

What drugs are being tested in NCT01980953?

Interventions in NCT01980953: GDC-0032 Phase III Tablet, GDC-0032 Tablet, GDC-0032 Capsule.

What condition does NCT01980953 study?

NCT01980953 studies Healthy Volunteer.

Is NCT01980953 still recruiting?

NCT01980953 is currently completed. Last updated 31 January 2017.

Last reviewed 2017-01-31 · How we verify

NCT01980953

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1, Open-Label Study to Evaluate the Effect of Particle Size, Formulation, and Food on the Pharmacokinetics of GDC-0032 in Healthy Subjects

Completed Phase 1 Last updated 31 January 2017

What this trial tests

Phase 1 trial testing GDC-0032 Phase III Tablet in Healthy Volunteer in 76 participants. Completed in 1 July 2014.

Timeline

1 November 2013

Primary endpoint
1 July 2014

1 July 2014

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	76
Start date	1 November 2013
Primary completion	1 July 2014
Estimated completion	1 July 2014
Sites	1 location across United States

Drugs / interventions tested

GDC-0032 Phase III Tablet — full drug profile →
GDC-0032 Tablet — full drug profile →
GDC-0032 Capsule

Conditions studied

Healthy Volunteer — all drugs for Healthy Volunteer →

Sponsor

Genentech, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteer. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t)
Time frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose
Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity)
Time frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour post-dose
Maximum Plasma Concentration (Cmax)
Time frame: Pre-dose (Hour 0), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 168, 192 hour postdose

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Genentech, Inc. trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01980953 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genentech, Inc.
Last refreshed: 31 January 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01980953.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing