NCT03381144

A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Multiple Ascending Doses of GDC-0334 and the Effect of Food on the Pharmacokinetics of GDC-0334 in Healthy Adult Participants

Terminated Phase 1 Last updated 18 October 2019

What this trial tests

Phase 1 trial testing GDC-0334 in Healthy Volunteers in 66 participants. Terminated before completion.

Timeline

8 December 2017

Primary endpoint
29 April 2019

29 April 2019

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	66
Start date	8 December 2017
Primary completion	29 April 2019
Estimated completion	29 April 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• GDC-0334 — full drug profile →
• Placebo

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Genentech, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, double-blind, placebo-controlled, single-center, three-part study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single and multiple ascending doses of GDC-0334 and the effect of food on the pharmacokinetics of GDC-0334 in healthy adult participants.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. TRP (transient receptor potential) ion channel family: structures, biological functions and therapeutic interventions for diseases.
   Zhang M, Ma Y, Ye X, Zhang N, et al · · 2023 · cited 303× · PMID 37402746 · DOI 10.1038/s41392-023-01464-x
2. A TRPA1 inhibitor suppresses neurogenic inflammation and airway contraction for asthma treatment.
   Balestrini A, Joseph V, Dourado M, Reese RM, et al · · 2021 · cited 104× · PMID 33620419 · DOI 10.1084/jem.20201637
3. Asthma in the Precision Medicine Era: Biologics and Probiotics.
   Chiu CJ, Huang MT. · · 2021 · cited 39× · PMID 33926084 · DOI 10.3390/ijms22094528
4. Transient receptor potential channels in pulmonary chemical injuries and as countermeasure targets.
   Achanta S, Jordt SE. · · 2020 · cited 26× · PMID 32892378 · DOI 10.1111/nyas.14472
5. Neuronal and non-neuronal TRPA1 as therapeutic targets for pain and headache relief.
   Iannone LF, Nassini R, Patacchini R, Geppetti P, et al · · 2023 · cited 18× · PMID 37187829 · DOI 10.1080/23328940.2022.2075218
6. Translational and pharmacokinetic-pharmacodynamic application for the clinical development of GDC-0334, a novel TRPA1 inhibitor.
   Chan P, Ding HT, Liederer BM, Mao J, et al · · 2021 · cited 17× · PMID 34058071 · DOI 10.1111/cts.13049
7. Setting the tone: nociceptors as conductors of immune responses.
   Hanč P, Messou MA, Ajit J, von Andrian UH. · · 2024 · cited 7× · PMID 39307581 · DOI 10.1016/j.it.2024.08.007
8. TRPA1 and TRPM8 in Allergic Rhinitis and Chronic Rhinosinusitis: Emerging Role in Neuroimmune Inflammation.
   Kang T, Qiu Z, Aodeng S, Liu Y, et al · · 2026 · PMID 42193342 · DOI 10.3390/biomedicines14051015