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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo; Drug: GDC-3280

• Registration Number: NCT02471859
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-15
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: Placebo	Placebo	Participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions.
Part A: GDC-3280	GDC-3280	Participants in multiple cohorts and treatment periods will receive single doses of GDC-3280 under fed/fasting conditions.
Part B: Placebo	Placebo	Participants in different cohorts will receive placebo in multiple ascending doses under fed/fasting conditions.\\n
Part B: GCD-3280	GDC-3280	Participants in different cohorts will receive GDC-3280 in multiple ascending doses under fed/fasting conditions.\\n

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing an adverse event	Up to approximately 6 months

Secondary Outcome Measures

Name	Time	Method
Total serum clearance for GDC-3280	Up to 4 days
Volume of distribution for GDC-3280	Up to 4 days
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
Serum GDC-3280 concentration-time data by dosing group	Up to 4 days