Phase 1
Completed N=38
A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential
Healthy Volunteers
Source: ClinicalTrials.gov NCT03807739 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Maximum Observed Concentration (Cmax) of GDC-0134. — 5.56; 4.45; 2.66; 2.68 uM
Summary
This is a two-part study to determine the relative bioavailability of two different prototype capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and fasted conditions. The study is open to healthy female participants of non-childbearing potential.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Concentration (Cmax) of GDC-0134. |
5.56; 4.45; 2.66; 2.68 | — |
| PRIMARY Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134 |
190; 154; 84.8; 85.6 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
63.2; 52.6 | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) range 18.5 to 35 kilograms per square meter (kg/m2)
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs;
- Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the principal investigators (PIs)
- Females of non-childbearing potential only
Exclusion Criteria
- History or clinical manifestation of any significant medical condition as determined by the PI (or designee)
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the PI (or designee)
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Use of any prescription medications/products within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration, unless deemed acceptable by the PI
- Use of oral antibiotics within 4 weeks or intravenous antibiotics within 8 weeks prior to the Screening evaluation and during the entire study duration
- Use of any over-the-counter, non-prescription preparations within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration, unless deemed acceptable by the PI
- Use of acid reducing medications (proton pump inhibitors [PPIs], histamine H2-receptor antagonists [H2RAs]) within 14 days prior to Check-in (Day -1) for their first treatment period and during the entire study duration. As an alternative, antacids may be allowed at least 4 hours before or after dose
- Use of any vaccines (including seasonal flu and H1N1 vaccines) within 14 days prior to Check-in (Day -1) for their first treatment period
- Use of tobacco- or nicotine-containing products within 6 months prior to Check-in (Day -1) for their first treatment period and during the entire study
- Any acute or chronic condition or any other reason that, in the opinion of the PI, would limit the subject's ability to complete and/or participate in this clinical study
Data sourced from ClinicalTrials.gov (NCT03807739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.