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Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants
- Neurodegenerative Disorder
- Amyotrophic Lateral Sclerosis
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
City
- Nottingham
Trial Identifier:
NCT03237741 2017-000299-27 GP39778
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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