NCT02742779

A Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers

A Phase I, Randomized, Single and Multiple Ascending Dose, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of single and multiple orally ascending doses of GDC-0310 administered in healthy participants as 4 parts including Part 1- a single dose (SD) part using a powder-in-capsule (PIC) formulation, Part 2- a multiple dose (MD) part using a PIC formulation, Part 3- a SD part using a solution formulation, and Part 4- a MD part using a solution formulation. Effects of food on pharmacokinetics (PK) will also be explored.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	GDC-0310	Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.
DRUG	Placebo	Participants will receive placebo matched to GDC-0310 as single or multiple oral dose in fasted or fed state.

Timeline

• Start date: 2015-09-15
• Primary completion: 2017-06-07
• Completion: 2017-06-07
• First posted: 2016-04-19
• Last updated: 2020-02-20

Locations

1 site across 1 country: United States