NCT02092831

Brief Summary

This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the relative bioavailability of GDC-0941 administered as a single dose of the market image formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the Phase 2 formulation to healthy male and female volunteers. Participants will be randomly assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation), and GDC-0941 will be administered based on the assigned sequence. The study is expected to last 8 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

March 18, 2014

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

  • Area under the concentration-time curve (AUC) of plasma GDC-0941

    25 Days

  • Maximum plasma concentration (Cmax) of GDC-0941

    25 Days

  • Relative bioavailability (Frel) according to the model independent approach

    25 days

Secondary Outcomes (2)

  • Incidence of adverse events

    25 days

  • Electrocardiogram (ECG)

    25 days

Study Arms (4)

Crossover sequence 1

EXPERIMENTAL
Drug: GDC-0941

Crossover sequence 2

EXPERIMENTAL
Drug: GDC-0941

Crossover sequence 3

EXPERIMENTAL
Drug: GDC-0941

Crossover sequence 4

EXPERIMENTAL
Drug: GDC-0941

Interventions

GDC-0941DRUG

Single dose market image tablet of hardness 1

Crossover sequence 1Crossover sequence 2Crossover sequence 3Crossover sequence 4

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female participants between 18 and 55 years of age, inclusive,
  • Body mass index (BMI) between 18.5 to 32 kg/m2, inclusive,
  • Healthy, as determined by no clinically significant findings from medical history, ECG, and vital signs, and who are able to swallow and tolerate a tethered Heidelberg pH Capsule and have gastric pH measurements taken

You may not qualify if:

  • Any medical condition or history of such condition that may, in the opinion of the investigator, contraindicate participation in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidine

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 20, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)