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Phase 1 Completed N=38 Randomized Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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