This is a randomized, double-blind, placebo-controlled, single-center, three-part study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single and multiple ascending doses of GDC-0334 and the effect of food on the pharmacokinetics of GDC-0334 in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
66
Part 1: GDC-0334 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Parts 2 and 3: doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration in Part 3 is planned to be at least 14 days, but no longer than 28 days.
Participants will receive GDC-0334-matching placebo.
Quotient Clinical Ltd, Clinical Research Unit
Nottingham, United Kingdom
Percentage of Participants with Adverse Events
Time frame: From signing of informed consent until 30 days after the last dose of study drug (Up to approximately 42 days)
Severity of Adverse Events, as Graded per the World Health Organization (WHO) Toxicity Grading Scale
Time frame: From signing of informed consent until 30 days after the last dose of study drug (Up to approximately 42 days)
Change from Baseline in Blood Pressure
Time frame: Up to approximately 42 days
Change from Baseline in Heart Rate
Time frame: Up to approximately 42 days
Incidence of Electrocardiogram (ECG) Abnormalities
Time frame: Up to approximately 42 days
Incidence of Clinical Laboratory Abnormalities
Time frame: Up to approximately 30 days
Incidence of Physical Examination Abnormalities
Time frame: Up to approximately 42 days
Incidence of Neurological Examination Abnormalities
Time frame: Up to approximately 31 days
Columbia-Suicide Severity Rating Scale (C-SSRS) - Part 3 Only
Time frame: Up to approximately 42 days
Elapsed Time from Dosing at Which GDC-0334 is First Quantifiable in a Concentration versus Time profile (Tlag )
Time frame: Up to approximately 35 days
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Time to Maximum Plasma Concentration (Tmax) for GDC-0334
Time frame: Up to approximately 35 days
Maximum Observed Plasma Concentration (Cmax) for GDC-0334
Time frame: Up to approximately 35 days
Concentration at 24 hours Post-dose (C24) for GDC-0334
Time frame: Up to approximately 35 days
Concentration at 12 hours Post-dose (C12) for GDC-0334
Time frame: Up to approximately 35 days
Area Under the Plasma Concentration Curve from Time Zero to the Last Measurable Concentration (AUC0-t) for GDC-0334
Time frame: Up to approximately 35 days
Area Under the Plasma Concentration Curve from Time Zero Extrapolated to Infinity (AUC0-inf) for GDC-0334
Time frame: Up to approximately 35 days
Percentage of AUC0-inf Accounted for by Extrapolation to Infinity (AUC%extrap) for GDC-0334
Time frame: Up to approximately 35 days
Apparent Terminal Elimination Half-Life (t1/2) for GDC-0334
Time frame: Up to approximately 35 days