Last reviewed · How we verify

NCT02742779

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

Completed Phase 1 Last updated 20 February 2020
What this trial tests

Phase 1 trial testing GDC-0310 in Healthy Volunteer in 95 participants. Completed in 7 June 2017.

Timeline
15 September 2015
Primary endpoint
7 June 2017
7 June 2017

Quick facts

Lead sponsorGenentech, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposebasic science
Enrollment95
Start date15 September 2015
Primary completion7 June 2017
Estimated completion7 June 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Genentech, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Inhibition of Na<sub>V</sub>1.7: the possibility of ideal analgesics.
    Kitano Y, Shinozuka T. · · 2022 · cited 13× · PMID 36092147 · DOI 10.1039/d2md00081d

Verify or expand the search:

Other recruiting trials for Healthy Volunteer

Currently open trials in the same condition.

Other Genentech, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02742779.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing