Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects

Genentech

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: Ipatasertib (capsule); Drug: Ipatasertib (tablet)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02536391

GO29868

Details and patient eligibility

About

This Phase I, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 3 weeks.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males or females, between 18 and 55 years of age, inclusive
• Body mass index between 18.5 and 29.9 kg/m^2, inclusive

Exclusion criteria

• Clinically significant findings from medical history or screening evaluations.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 6 patient groups

Sequence 1: Tablet/Capsule/Tablet with food

Experimental group

Description:

Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after high-fat meal.

Treatment:

Drug: Ipatasertib (tablet)

Drug: Ipatasertib (capsule)

Sequence 2: Tablet/Tablet with food/Capsule

Experimental group

Description:

Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib capsule administered after fast.

Treatment:

Drug: Ipatasertib (tablet)

Drug: Ipatasertib (capsule)

Sequence 3: Capsule/Tablet/Tablet with food

Experimental group

Description:

Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib tablet administered after high-fat meal.

Treatment:

Drug: Ipatasertib (tablet)

Drug: Ipatasertib (capsule)

Sequence 4: Capsule/Tablet with food/Tablet

Experimental group

Description:

Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib tablet administered after fast.

Treatment:

Drug: Ipatasertib (tablet)

Drug: Ipatasertib (capsule)

Sequence 5: Tablet with food/Tablet/Capsule

Experimental group

Description:

Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib capsule administered after fast.

Treatment:

Drug: Ipatasertib (tablet)

Drug: Ipatasertib (capsule)

Sequence 6: Tablet with food/Capsule/Tablet

Experimental group

Description:

Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after fast.

Treatment:

Drug: Ipatasertib (tablet)

Drug: Ipatasertib (capsule)