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

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: GDC-3280; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02471859

2015-000560-33 (EudraCT Number)

GB29751

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 4 patient groups, including a placebo group

Part A: GDC-3280

Experimental group

Description:

Participants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions.

Treatment:

Drug: GDC-3280

Part A: Placebo

Placebo Comparator group

Description:

Participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions.

Treatment:

Drug: Placebo

Part B: GCD-3280

Experimental group

Description:

Participants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\\n

Treatment:

Drug: GDC-3280

Part B: Placebo

Placebo Comparator group

Description:

Participants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\\n

Treatment:

Drug: Placebo