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NCT Number: NCT03807739

A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Covance Research Unit - Daytona, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0134 F09 Formulation

Drug

Participants will receive a single oral dose of GDC-0134 reference capsule F09.

GDC-0134 F15 Formulation

Drug

Participants will receive a single oral dose of GDC-0134 prototype capsule F15.

GDC-0134 F16 Formulation

Drug

Participants will receive a single oral dose of GDC-0134 prototype capsule F16.

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of GDC-0134.

    Time frame: The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.

  2. Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134

    Time frame: The time points at which the outcome measure was assessed were 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 336, 504 hours post-dose.

Secondary outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: From baseline through the end of study (approximately 11 weeks)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase I Study to Determine the Relative Bioavailability of Various Formulations of GDC-0134 in Healthy Female Subjects of Non-Childbearing Potential

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 17, 2019
Registry last updated
Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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