Status:
COMPLETED
Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Quotient Clinical
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
FEMALE
30-65 years
Phase:
PHASE1
Brief 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 proto...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03237741
Start Date
August 7 2017
End Date
December 14 2017
Last Update
March 1 2024
Active Locations (1)
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1
Quotient Clinical Ltd, Clinical Research Unit
Nottingham, United Kingdom, NG11 6JS