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Completed

NCT Number: NCT03290703

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical Ltd, Clinical Research Unit

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0853

Drug

Participants will receive different formulations of GDC-0853 tablet.

Other names: RO7010939

rabeprazole

Drug

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 outcomes

  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 outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: From screening to the end of the study (approximately a maximum of 11 weeks)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2017
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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