A Study to Assess the Relative Bioavailability And Food Effect of a Tablet Formulation of GDC-0276 in Healthy Participants
NCT ID: NCT02856152
Last Updated: 2018-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2016-06-30
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Treatment A Then B Then D Then C
Treatment A: a single dose of three 90-mg capsules of GDC-0276 administered orally after at least an 8-hour fast. Treatment B: a single dose of three 90-mg tablets GDC-0276 administered orally after at least an 8-hour fast. Treatment C: a single dose of three 90-mg tablets of GDC-0276 administered orally within 30 minutes of eating a standardized FDA high-fat meal. Treatment D: a single dose of three 90-mg tablets of GDC-0276 administered orally within 30 minutes of eating a standardized low-fat meal. Participants will receive Treatment A on Day 1 of first intervention period, followed by Treatment B on Day 1 of second intervention period, followed by Treatment D on Day 1 of third intervention period, and then Treatment C on Day 1 of fourth intervention period. A washout period of 6 days will be maintained between each intervention period.
GDC-0276 capsule
Three 90 milligram \[mg\] capsules of GDC-0276 administered orally.
GDC-0276 tablets
Three 90 mg GDC-0276 tablets administered orally.
Treatment B, Then C, Then A, Then D
Treatment A: a single dose of three 90-mg capsules of GDC-0276 administered orally after at least an 8-hour fast. Treatment B: a single dose of three 90-mg tablets GDC-0276 administered orally after at least an 8-hour fast. Treatment C: a single dose of three 90-mg tablets of GDC-0276 administered orally within 30 minutes of eating a standardized FDA high-fat meal. Treatment D: a single dose of three 90-mg tablets of GDC-0276 administered orally within 30 minutes of eating a standardized low-fat meal. Participants will receive Treatment B on Day 1 of first intervention period, followed by Treatment C on Day 1 of second intervention period, followed by Treatment A on Day 1 of third intervention period, and then Treatment D on Day 1 of fourth intervention period. A washout period of 6 days will be maintained between each intervention period.
GDC-0276 capsule
Three 90 milligram \[mg\] capsules of GDC-0276 administered orally.
GDC-0276 tablets
Three 90 mg GDC-0276 tablets administered orally.
Treatment C, Then D, Then B, Then A
Treatment A: a single dose of three 90-mg capsules of GDC-0276 administered orally after at least an 8-hour fast. Treatment B: a single dose of three 90-mg tablets GDC-0276 administered orally after at least an 8-hour fast. Treatment C: a single dose of three 90-mg tablets of GDC-0276 administered orally within 30 minutes of eating a standardized FDA high-fat meal. Treatment D: a single dose of three 90-mg tablets of GDC-0276 administered orally within 30 minutes of eating a standardized low-fat meal. Participants will receive Treatment C on Day 1 of first intervention period, followed by Treatment D on Day 1 of second intervention period, followed by Treatment B on Day 1 of third intervention period, and then Treatment A on Day 1 of fourth intervention period. A washout period of 6 days will be maintained between each intervention period.
GDC-0276 capsule
Three 90 milligram \[mg\] capsules of GDC-0276 administered orally.
GDC-0276 tablets
Three 90 mg GDC-0276 tablets administered orally.
Treatment D, Then A, Then C, Then B
Treatment A: a single dose of three 90-mg capsules of GDC-0276 administered orally after at least an 8-hour fast. Treatment B: a single dose of three 90-mg tablets GDC-0276 administered orally after at least an 8-hour fast. Treatment C: a single dose of three 90-mg tablets of GDC-0276 administered orally within 30 minutes of eating a standardized FDA high-fat meal. Treatment D: a single dose of three 90-mg tablets of GDC-0276 administered orally within 30 minutes of eating a standardized low-fat meal. Participants will receive Treatment D on Day 1 of first intervention period, followed by Treatment A on Day 1 of second intervention period, followed by Treatment C on Day 1 of third intervention period, and then Treatment B on Day 1 of fourth intervention period. A washout period of 6 days will be maintained between each intervention period.
GDC-0276 capsule
Three 90 milligram \[mg\] capsules of GDC-0276 administered orally.
GDC-0276 tablets
Three 90 mg GDC-0276 tablets administered orally.
Interventions
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GDC-0276 capsule
Three 90 milligram \[mg\] capsules of GDC-0276 administered orally.
GDC-0276 tablets
Three 90 mg GDC-0276 tablets administered orally.
Eligibility Criteria
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Inclusion Criteria
* Male participants of reproductive potential must be and willing to continue using medically acceptable contraception and must avoid sperm donation from screening and for at least 90 days after the last study drug administration
Exclusion Criteria
* Have used any prescription or over-the-counter (OTC) medication or supplement within 14 days or 5 times the elimination half-life (whichever is longer) before Day -1 until the end of their participation in the study
* Have used any vaccine within 7 days before GDC-0276 administration
* Female participants with a positive serum or urine pregnancy test or are breast feeding
* Donation or loss of more than 500 milliliter (mL) whole blood within 3 months preceding entry into the treatment period
* Blood transfusion within 30 days preceding entry into the treatment period
18 Years
55 Years
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Quotient Clinical Ltd, Clinical Research Unit
Nottingham, , United Kingdom
Countries
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Other Identifiers
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2016-001572-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GX29841
Identifier Type: -
Identifier Source: org_study_id
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