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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.

Tracking Information
First Submitted Date  ICMJE September 19, 2017
First Posted Date  ICMJE September 25, 2017
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE April 18, 2017
Actual Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03290703 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
Percentage of Participants With Adverse Events (AEs) [ Time Frame: From screening to the end of the study (approximately a maximum of 11 weeks) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: GDC-0853
    • Drug: Rabeprazole
  • 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.
    Interventions:
    • Drug: GDC-0853
    • Drug: Rabeprazole
  • 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.
    Interventions:
    • Drug: GDC-0853
    • Drug: Rabeprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2017)
63
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 25, 2018
Actual Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03290703
Other Study ID Numbers  ICMJE GP39619
2017-000752-26 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP