Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants

  • Amyotrophic Lateral Sclerosis
Trial Status:

Completed

This trial runs in
Countries
  • United Kingdom
Trial Identifier:

NCT03237741 2017-000299-27 GP39778

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      This study will evaluate the pharmacokinetics and safety of GDC-0134 in healthy female volunteers of non-childbearing potential. The first part of the study will compare the bioavailability of a prototype capsule of GDC-0134 relative to an existing GDC-0134 reference capsule (Periods 1 and 2). The second part of the study will assess the effect of GDC-0134-in-applesauce preparation under fasting conditions, the effect of low and high fat foods as well as the effect of elevated stomach pH via pre-treatment with rabeprazole, a proton pump inhibitor (PPI), under fasted and high-fat meal conditions (Periods 3 and 4).

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT03237741 , GP39778 , 2017-000299-27 Trial Identifier
      Reference capsule GDC-0134, Prototype capsule GDC-0134, rabeprazole Treatments
      Amyotrophic Lateral Sclerosis Condition
      Official Title

      A Phase I Open-Label Study to Determine the Relative Bioavailability of GDC-0134 and to Investigate the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Subjects of Non-childbearing Potential

      Eligibility Criteria

      Female Gender
      ≥ 30 Years & ≤ 65 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • Healthy female participants between 30 and 65 years of age, inclusive;
      • Within body mass index range 18.0 to 35.0 kilograms per square meter (kg/m^2), inclusive;
      • Female participants will be of non-childbearing potential;
      • In good health, determined by no clinically significant findings from medical history, 12-lead echocardiogram (ECG), and vital signs;
      • Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the investigator;
      • Normal ophthalmology assessment.
      Exclusion Criteria
      • Males and females of childbearing potential;
      • Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the investigator;
      • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator;
      • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs;
      • History of GI bleeding or GI ulcers;
      • Any personal or family history of bleeding disorders, and any personal use of drugs known to affect blood clotting within 30 days of dosing;
      • Any acute or chronic medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the subject's safe participation in and completion of the study.

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