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

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ClinicalTrials.gov Identifier: NCT03290703
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: GDC-0853 Drug: Rabeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : October 25, 2018

Resource links provided by the National Library of Medicine


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.
Drug: GDC-0853
Participants will receive different formulations of GDC-0853 tablet.
Other Name: RO7010939

Drug: 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.

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.
Drug: GDC-0853
Participants will receive different formulations of GDC-0853 tablet.
Other Name: RO7010939

Drug: 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.

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.
Drug: GDC-0853
Participants will receive different formulations of GDC-0853 tablet.
Other Name: RO7010939

Drug: 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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) [ Time Frame: From screening to the end of the study (approximately a maximum of 11 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290703


Locations
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United Kingdom
Quotient Clinical Ltd, Clinical Research Unit
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trial Hoffmann-La Roche

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03290703     History of Changes
Other Study ID Numbers: GP39619
2017-000752-26 ( EudraCT Number )
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action