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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807739
• Other study ID #: GP40957
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2019
• Est. completion date: May 30, 2019

Study information

• Verified date: August 2020
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• GDC-0134 F09 Formulation
Participants will receive a single oral dose of GDC-0134 reference capsule F09.
• GDC-0134 F15 Formulation
Participants will receive a single oral dose of GDC-0134 prototype capsule F15.
• GDC-0134 F16 Formulation
Participants will receive a single oral dose of GDC-0134 prototype capsule F16.

Locations

Country	Name	City	State
United States	Covance Research Unit - Dallas	Dallas	Texas
United States	Covance Research Unit - Daytona	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentration (Cmax) of GDC-0134.		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.
Primary	Area Under the Curve Extrapolated to Infinity (AUCinf) of GDC-0134		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	Percentage of Participants With Adverse Events (AEs)		From baseline through the end of study (approximately 11 weeks)