A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants

NCT03290703 | Completed Phase 1

• 2 other identifiers: GP396192017-000752-26
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both. This will be a 3-part open-label randomized study conducted in healthy adult participants. Approximately 63 subjects will be enrolled in this study.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (10)

• Maximum Observed Plasma Concentration (Cmax) of GDC-0853

  Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of GDC-0853

  Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part

• Area Under the Curve From Time Zero to Last Measurable Concentration [AUC (0-t)] of GDC-0853

  Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of GDC-0853

  Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part

• Extrapolated Area Under the Curve (AUC Percent [%] Extrap) of GDC-0853

  Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part

• Apparent Terminal Elimination Rate Constant of GDC-0853

  Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part

• Apparent Volume of Distribution (Vz/F) of GDC-0853

  Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part

• Apparent Oral Clearance (CL/F) of GDC-0853

  Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part

• Relative Bioavailability (Frel) of GDC-0853

  Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part

• Apparent Terminal Elimination Half-Life (t1/2) of GDC-0853

  Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part

Secondary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  From screening to the end of the study (approximately a maximum of 11 weeks)

Study Arms (3)

Part 1: GDC-0853 (Effect of Formulation)

EXPERIMENTAL

Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state.

Drug: GDC-0853; Drug: Rabeprazole

Part 2: GDC-0853 (Effect of Food and Rabeprazole)

EXPERIMENTAL

Participants will receive three single oral doses of one GDC-0853 formulations selected from Part 1 of this study. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.

Drug: GDC-0853; Drug: Rabeprazole

Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)

EXPERIMENTAL

Participants will receive three single oral doses of an optimized tablet formulations of GDC-0853. One dose will be administered in the fasted state, one dose will be administered in the fed state, and one dose will be co-administered with rabeprazole in the fed or fasted state, depending on randomization.

Drug: GDC-0853; Drug: Rabeprazole

Interventions

GDC-0853 DRUG

Participants will receive different formulations of GDC-0853 tablet.

Also known as: RO7010939

Part 1: GDC-0853 (Effect of Formulation); Part 2: GDC-0853 (Effect of Food and Rabeprazole); Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)

Rabeprazole DRUG

Participants will receive rabeprazole 20 mg twice daily (BID) for three days prior to GDC-0853 administration and a single dose coadministered with GDC-0853.

Part 1: GDC-0853 (Effect of Formulation); Part 2: GDC-0853 (Effect of Food and Rabeprazole); Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female (of non-childbearing potential) participants
• Within body mass index range 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive
• In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs and physical examinations
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

You may not qualify if:

• History or symptoms of any significant disease
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
• History of stomach or intestinal surgery or resection
• Participants who previously participated in any other investigational study drug trial within 90 days prior to Check-in. Participants who previously received GDC-0853 in previous studies.
• History of malignancy
• Pregnancy, lactation, or breastfeeding in female participants

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Quotient Clinical Ltd, Clinical Research Unit

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

fenebrutinib; Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Clinical Trial

  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: September 19, 2017
• First Posted: September 25, 2017
• Study Start: April 18, 2017
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

GB (1)