GDC-0134 F09 Formulation
DrugParticipants will receive a single oral dose of GDC-0134 reference capsule F09.
NCT Number: NCT03807739
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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Notify Me18 year–65 year
Female
Interventional
Phase 1
Covance Research Unit - Daytona, Daytona Beach, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single oral dose of GDC-0134 reference capsule F09.
Participants will receive a single oral dose of GDC-0134 prototype capsule F15.
Participants will receive a single oral dose of GDC-0134 prototype capsule F16.
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.
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.
Time frame: From baseline through the end of study (approximately 11 weeks)
Genentech, Inc.
Industry
A Phase I Study to Determine the Relative Bioavailability of Various Formulations of GDC-0134 in Healthy Female Subjects of Non-Childbearing Potential
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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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