Healthy VolunteerPhase 1NCT02856152

A Study to Assess the Relative Bioavailability And Food Effect of a Tablet Formulation of GDC-0276 in Healthy Participants

A Phase 1 study testing GDC-0276 capsule and GDC-0276 tablets in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This open-label, randomized, 4-way crossover study in healthy participants will determine the relative bioavailability of the tablet formulation relative to the capsule formulation and the effect of a high-fat and low-fat meal on the relative bioavailability of the tablet formulation. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: GDC-0276 capsule and GDC-0276 tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited Kingdom
Study dates: Jun 2016to Nov 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index within the range 18.0 to 32.0 kilograms per meter squared (kg/m^2), inclusive, and a minimum weight of 50.0 kg
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

Who cannot join

Self-reported substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, and/or participants who have ever been in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence
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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Quotient Clinical Ltd, Clinical Research Unit
Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Single-dose, Open-label, Randomized, 4-way Crossover Study to Assess the Relative Bioavailability And Food Effect of a Tablet Formulation of GDC-0276 in Healthy Subjects

Conditions: Healthy Volunteer
Being tested: GDC-0276 capsule, GDC-0276 tablets
Keywords: Healthy Volunteer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GDC-0276 capsuleDrug
Three 90 milligram [mg] capsules of GDC-0276 administered orally.
GDC-0276 tabletsDrug
Three 90 mg GDC-0276 tablets administered orally.

Study groups in NCT02856152
Study group	Role	What they receive
Treatment A Then B Then D Then C	Experimental	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. Receives: Drug: GDC-0276 capsule; Drug: GDC-0276 tablets
Treatment B, Then C, Then A, Then D	Experimental	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. Receives: Drug: GDC-0276 capsule; Drug: GDC-0276 tablets
Treatment C, Then D, Then B, Then A	Experimental	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. Receives: Drug: GDC-0276 capsule; Drug: GDC-0276 tablets
Treatment D, Then A, Then C, Then B	Experimental	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. Receives: Drug: GDC-0276 capsule; Drug: GDC-0276 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Cmax of M12 Metabolite of GDC-0276
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Maximum Plasma Concentration (Cmax) of GDC-0276
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Cmax of M16 Metabolite of GDC-0276
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of GDC-0276
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu) of M12 Metabolite of GDC-0276
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu) of M16 Metabolite of GDC-0276
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] of GDC-0276
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] of M12 Metabolite of GDC-0276
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] of M16 Metabolite of GDC-0276
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose

Secondary outcomes (13)

Time to Reach Maximum Observed Plasma Concentration (Tmax) of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of M12 Metabolite of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of M16 Metabolite of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Apparent Oral Clearance (CL/F) of GDC-0276 Following Tablet and Capsule Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Apparent Oral Clearance (CL/F) of M12 Metabolite of GDC-0276 Following Tablet and Capsule Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Apparent Oral Clearance (CL/F) of M16 Metabolite of GDC-0276 Following Tablet and Capsule Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Apparent Volume of Distribution (Vz/F) of GDC-0276 Following Tablet and Capsule Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Apparent Volume of Distribution (Vz/F) of M12 Metabolite of GDC-0276 Following Tablet and Capsule Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Plasma Terminal Half-Life (t1/2) of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Plasma Terminal Half-Life (t1/2) of M12 Metabolite of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Plasma Terminal Half-Life (t1/2) of M16 Metabolite of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Number of Participants With Adverse Events and Serious Adverse Event
Measured: Baseline up to Follow up (Day 32)
Apparent Volume of Distribution (Vz/F) of M16 Metabolite of GDC-0276 Following Tablet and Capsule Dosing
Measured: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Nov 2016

First posted4 Aug 2016 (estimated)
Study startJun 2016
Primary completionNov 2016 (estimated)
Study completionNov 2016 (estimated)

Why it stopped: The molecule (GDC-276) is no longer in development.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02856152
Sponsor's protocol ID: GX29841
Other IDs: 2016-001572-30, 2016
Status last verified: Feb 2018
First submitted: 29 Jul 2016
Last updated: 19 Feb 2018
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-dose, Open-label, Randomized, 4-way Crossover Study to Assess the Relative Bioavailability And Food Effect of a Tablet Formulation of GDC-0276 in Healthy Subjects
ClinicalTrials.gov ID: NCT02856152
Acronym / sponsor ID: GX29841
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The molecule (GDC-276) is no longer in development.
Enrolment: 0 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: Nov 2016 (estimated)
Study completion: Nov 2016 (estimated)
First posted: 4 Aug 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment A Then B Then D Then C	Experimental	Drug: GDC-0276 capsule, Drug: GDC-0276 tabletsTreatment 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.
Treatment B, Then C, Then A, Then D	Experimental	Drug: GDC-0276 capsule, Drug: GDC-0276 tabletsTreatment 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.
Treatment C, Then D, Then B, Then A	Experimental	Drug: GDC-0276 capsule, Drug: GDC-0276 tabletsTreatment 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.
Treatment D, Then A, Then C, Then B	Experimental	Drug: GDC-0276 capsule, Drug: GDC-0276 tabletsTreatment 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Body mass index within the range 18.0 to 32.0 kilograms per meter squared (kg/m^2), inclusive, and a minimum weight of 50.0 kg
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

Key exclusion criteria (6 listed)

Self-reported substance or alcohol dependence (excluding nicotine and caffeine) within the past 2 years, and/or participants who have ever been in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GDC-0276 capsuleThree 90 milligram [mg] capsules of GDC-0276 administered orally.	Drug	Treatment A Then B Then D Then C, Treatment B, Then C, Then A, Then D, Treatment C, Then D, Then B, Then A, Treatment D, Then A, Then C, Then B
GDC-0276 tabletsThree 90 mg GDC-0276 tablets administered orally.	Drug	Treatment A Then B Then D Then C, Treatment B, Then C, Then A, Then D, Treatment C, Then D, Then B, Then A, Treatment D, Then A, Then C, Then B

Primary outcome

Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Cmax of M12 Metabolite of GDC-0276
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Maximum Plasma Concentration (Cmax) of GDC-0276
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Cmax of M16 Metabolite of GDC-0276
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of GDC-0276
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu) of M12 Metabolite of GDC-0276
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastu) of M16 Metabolite of GDC-0276
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] of GDC-0276
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] of M12 Metabolite of GDC-0276
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] of M16 Metabolite of GDC-0276
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose

13 secondary outcomes

Time to Reach Maximum Observed Plasma Concentration (Tmax) of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of M12 Metabolite of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of M16 Metabolite of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Apparent Oral Clearance (CL/F) of GDC-0276 Following Tablet and Capsule Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Apparent Oral Clearance (CL/F) of M12 Metabolite of GDC-0276 Following Tablet and Capsule Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Apparent Oral Clearance (CL/F) of M16 Metabolite of GDC-0276 Following Tablet and Capsule Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Apparent Volume of Distribution (Vz/F) of GDC-0276 Following Tablet and Capsule Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Apparent Volume of Distribution (Vz/F) of M12 Metabolite of GDC-0276 Following Tablet and Capsule Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Plasma Terminal Half-Life (t1/2) of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Plasma Terminal Half-Life (t1/2) of M12 Metabolite of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Plasma Terminal Half-Life (t1/2) of M16 Metabolite of GDC-0276 Following High-fat Meals, low-fat Meals and in Fasted State on a Tablet Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose
Number of Participants With Adverse Events and Serious Adverse Event
Time frame: Baseline up to Follow up (Day 32)
Apparent Volume of Distribution (Vz/F) of M16 Metabolite of GDC-0276 Following Tablet and Capsule Dosing
Time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GDC-0276 capsule and GDC-0276 tablets in people with Healthy Volunteer, run by Genentech, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Bioavailability: Geometric Mean Ratio (Tablet/Capsule) of Log Transformed Cmax of M12 Metabolite of GDC-0276 (time frame: Pre-dose (within 0.5 hours of dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 hours post-Day 1, or Day 7, or Day 13, or Day 19 dose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02856152.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.