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
NCT03237741 2017-000299-27 GP39778
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The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.
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).
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
- 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.
- 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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