A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants

Genentech, Inc.8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteer

Interventions

GDC-3280DRUG

GDC-3280 at various doses, depending on the cohort and treatment period

PlaceboDRUG

Placebo at various doses, depending on the cohort and treatment period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Leeds, United Kingdom

Outcomes

Primary Outcomes

Number of participants experiencing an adverse event

Time frame: Up to approximately 6 months

Secondary Outcomes

Maximum concentration (Cmax) for GDC-3280

Time frame: Up to 4 days

Time to Cmax (Tmax) for GDC-3280

Time frame: Up to 4 days

Total serum clearance for GDC-3280

Time frame: Up to 4 days

Volume of distribution for GDC-3280

Time frame: Up to 4 days

Elimination half-life for GDC-3280

Time frame: Up to 4 days

Serum GDC-3280 concentration-time data by dosing group

Time frame: Up to 4 days

Data from ClinicalTrials.gov

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