Who is sponsoring NCT01249118?

NCT01249118 is sponsored by Genentech, Inc..

What condition does NCT01249118 study?

NCT01249118 studies Healthy Volunteers.

What drugs are being tested in NCT01249118?

Interventions: GDC-0973 IV Infusion, GDC-0973 Oral Capsules.

What is the status of NCT01249118?

NCT01249118 is currently COMPLETED.

Last reviewed 2017-04-04 · How we verify

A Phase 1, Single Dose, Randomized, Cross-over Absolute Bioavailability Study in Healthy Subjects Comparing Oral to Intravenous Administration of GDC-0973

NCT01249118 Phase 1 COMPLETED Results posted

The primary objective of Part 1 of this study is to evaluate the safety and tolerability of the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this study is to evaluate the safety of GDC-0973 administered orally and intravenously.

Details

Lead sponsor	Genentech, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	13
Start date	2010-11
Completion	2011-01

Conditions

Healthy Volunteers

Interventions

GDC-0973 IV Infusion
GDC-0973 Oral Capsules

Primary outcomes

Maximum Observed Plasma Concentration (Cmax) of IV and Oral GDC-0973 — Part 2: 0 hours (Hrs) (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1
Dose Normalized Cmax [Cmax(dn)] of IV and Oral GDC-0973 — Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1
Cmax(dn) is Cmax divided by dose.
Minimum Observed Plasma Trough Concentration (Cmin) of IV and Oral GDC-0973 — Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of IV and Oral GDC-0973 — Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of IV and Oral GDC-0973 — Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).
Dose Normalized AUC (0-t) [AUC (0-t)dn] of IV and Oral GDC-0973 — Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). AUC (0-t)dn is AUC (0-t) divided by dose.