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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

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03290703
Collaborator
(none)
63
Enrollment
1
Location
3
Arms
18.2
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Apr 18, 2017
Actual Primary Completion Date :
Oct 25, 2018
Actual Study Completion Date :
Oct 25, 2018

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. 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]

    5. 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]

    6. 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]

    7. 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]

    8. 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]

    9. 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]

    10. 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 Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Quotient Clinical Ltd, Clinical Research Unit Nottingham United Kingdom NG11 6JS

    Sponsors and Collaborators

    • Genentech, Inc.

    Investigators

    • Study Director: Clinical Trial, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT03290703
    Other Study ID Numbers:
    • GP39619
    • 2017-000752-26
    First Posted:
    Sep 25, 2017
    Last Update Posted:
    Sep 11, 2019
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rabeprazole

    Study Results

    No Results Posted as of Sep 11, 2019