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

Genentech

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: GDC-0276 tablets; Drug: GDC-0276 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02856152

GX29841

2016-001572-30 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

0 participants in 4 patient groups

Treatment A Then B Then D Then C

Experimental group

Description:

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.

Treatment:

Drug: GDC-0276 capsule

Drug: GDC-0276 tablets

Treatment B, Then C, Then A, Then D

Experimental group

Description:

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.

Treatment:

Drug: GDC-0276 capsule

Drug: GDC-0276 tablets

Treatment C, Then D, Then B, Then A

Experimental group

Description:

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.

Treatment:

Drug: GDC-0276 capsule

Drug: GDC-0276 tablets

Treatment D, Then A, Then C, Then B

Experimental group

Description:

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.

Treatment:

Drug: GDC-0276 capsule

Drug: GDC-0276 tablets