- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03290703
A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants
September 10, 2019 updated by: Genentech, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nottingham, United Kingdom, NG11 6JS
- Quotient Clinical Ltd, Clinical Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: GDC-0853 (Effect of Formulation)
Participants will receive five single oral doses of test formulations of GDC-0853 co-administered with rabeprazole in the fasted state.
|
Participants will receive different formulations of GDC-0853 tablet.
Other Names:
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.
|
Experimental: Part 2: GDC-0853 (Effect of Food and Rabeprazole)
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.
|
Participants will receive different formulations of GDC-0853 tablet.
Other Names:
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.
|
Experimental: Part 3: GDC-0853 Optimized (Effect of Food and Rabeprazole)
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.
|
Participants will receive different formulations of GDC-0853 tablet.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Observed Plasma Concentration (Cmax) of GDC-0853
Time Frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
|
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
Time Frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
|
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
Time Frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
|
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
Time Frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
|
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
Time Frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
|
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
Time Frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
|
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
Time Frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
|
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
Time Frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
|
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
Time Frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
|
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
Time Frame: Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
|
Pre-dose (within 1 hour) and 0.5 hours up to 72 hours post-dose on Day 1 of each Part
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants With Adverse Events (AEs)
Time Frame: From screening to the end of the study (approximately a maximum of 11 weeks)
|
From screening to the end of the study (approximately a maximum of 11 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2017
Primary Completion (Actual)
October 25, 2018
Study Completion (Actual)
October 25, 2018
Study Registration Dates
First Submitted
September 19, 2017
First Submitted That Met QC Criteria
September 19, 2017
First Posted (Actual)
September 25, 2017
Study Record Updates
Last Update Posted (Actual)
September 11, 2019
Last Update Submitted That Met QC Criteria
September 10, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GP39619
- 2017-000752-26 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Inmagene LLCRecruitingHealthy VolunteersAustralia
Clinical Trials on GDC-0853
-
Genentech, Inc.TerminatedLupus Erythematosus, SystemicUnited States, Korea, Republic of, Spain, Taiwan, Bulgaria, Colombia, Brazil, Argentina, Mexico, Chile, United Kingdom
-
Genentech, Inc.CompletedLymphocytic Leukemia, Chronic, Diffuse Large B-Cell LymphomaUnited States, Australia
-
Genentech, Inc.CompletedUrticariaUnited States, Germany, Canada
-
Hoffmann-La RocheCompleted
-
Genentech, Inc.Terminated
-
Genentech, Inc.CompletedSystemic Lupus ErythematosusUnited States, Korea, Republic of, Spain, Taiwan, Bulgaria, Colombia, Argentina, Brazil, Mexico, United Kingdom, Chile, Germany
-
Genentech, Inc.CompletedHealthy ParticipantsUnited States
-
Genentech, Inc.CompletedRheumatoid ArthritisUnited States, Serbia, Bulgaria, Ukraine, Poland, Russian Federation, Argentina, Brazil, Colombia, Mexico
-
Philipps University Marburg Medical CenterCompletedDiabetes Mellitus Type 2Germany
-
Genentech, Inc.CompletedRheumatoid ArthritisUnited States, Korea, Republic of, Serbia, Argentina, Bulgaria, Poland, Ukraine, Colombia, Russian Federation, Brazil, Mexico