Status:
COMPLETED
A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2018
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03290703
Start Date
April 18 2017
End Date
October 25 2018
Last Update
September 11 2019
Active Locations (1)
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1
Quotient Clinical Ltd, Clinical Research Unit
Nottingham, United Kingdom, NG11 6JS