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

Healthy Volunteers Clinical Trial

Official title:

A Phase I, Single Center, Randomized, Open-Label Study Investigating the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics of GDC-0853 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290703
• Other study ID #: GP39619
• Secondary ID: 2017-000752-26
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2017
• Est. completion date: October 25, 2018

Study information

• Verified date: September 2019
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• GDC-0853
Participants will receive different formulations of GDC-0853 tablet.
• Rabeprazole
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.

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical Ltd, Clinical Research Unit	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Percentage of Participants With Adverse Events (AEs)		From screening to the end of the study (approximately a maximum of 11 weeks)