Healthy Volunteer
Conditions
Brief summary
This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.
Interventions
DRUGPlacebo
Placebo at various doses, depending on the cohort and treatment period
DRUGGDC-3280
GDC-3280 at various doses, depending on the cohort and treatment period
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Is male or female, using highly effective contraception * Has a body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive * Is in good general health * Having signed informed consent, is willing and able to comply with requirements of the study
Exclusion criteria
* Does not satisfy all screening criteria per protocol * Is employed by or related to any personnel involved in the trial * Has any history or condition that per protocol or in the opinion of the investigator could compromise the participant's safety or analysis of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants experiencing an adverse event | Up to approximately 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) for GDC-3280 | Up to 4 days |
| Time to Cmax (Tmax) for GDC-3280 | Up to 4 days |
| Elimination half-life for GDC-3280 | Up to 4 days |
| Volume of distribution for GDC-3280 | Up to 4 days |
| Serum GDC-3280 concentration-time data by dosing group | Up to 4 days |
| Total serum clearance for GDC-3280 | Up to 4 days |
Countries
United Kingdom
Outcome results
None listed