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NCT02136524 · ClinicalTrials.gov registry record · Phase 1

A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation

A Phase 1 study, sponsored by Genentech.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT02136524: Completed Phase 1 study, sponsored by Genentech.

NCT02136524 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02136524, a Phase 1 study, has completed, sponsored by Genentech.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence crossover study to determine the relative bioavailability of cobimetinib administered as a single dose of the tablet formulation relative to a single dose of the capsule formulation to healthy male and female participants. A minimum of 24 participants (12 participants per sequence) will complete the study. Participants will be randomly assigned to 2 possible sequences (i.e., I: A/B, II: B/A) where the treatments are as follows: Treatment A: One cobimetinib tablet administered as a single oral dose after at least an 8-hour fast; Treatment B: Four cobimetinib capsules administered as a single oral dose after at least an 8-hour fast. The study is expected to last approximately 7 weeks.

Interventions

  • DRUG cobimetinib

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2014-04
Est. Completion 2014-05
Phase Phase 1
Genentech

332 total trials

What the finished NCT02136524 record still lists

NCT02136524 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 1 intervention - of which cobimetinib is the first listed.

NCT02136524 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02136524 about?

NCT02136524 is a clinical study titled "A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation". This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence crossover study to determine the relative bioavailability of cobimetinib administered as a single dose of the tablet formulation relative to a single dose of the capsule formulation to healthy male and female partic...

What is the current status of trial NCT02136524?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2014-04. Estimated completion is 2014-05.

What interventions are being tested in trial NCT02136524?

The interventions under investigation include: cobimetinib (DRUG).

Who is sponsoring clinical trial NCT02136524?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02136524's enrollment target sits among peer trials

28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02136524, the US trial registry maintained by the National Library of Medicine. NCT02136524 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.