A study of a new medicine for asthma and cough: GDC-6599, a TRPA1 inhibitor

Respiratory Disorder
Asthma

For Patient
For Medical Professional
Results
Download
Print

Basic Details

Gender

All

Age

18 to 75 Years

Healthy Volunteers

Yes

Sponsor Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland)

Phase Phase 1

Study Identifier GA43010, 2021-002464-48

GDC-6599, a new TRPA1 inhibitor, is under development for the treatment of asthma and cough. This trial was conducted at a single study center in the Netherlands, involving 81 healthy volunteers. Some were given GDC-6599. Others were given a fake medicine (placebo) that did not have any real medicine in it. Results from the study showed no serious side effects. Thirteen people had non-serious side effects that doctors thought were related to the treatments.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What you can do next

Save the study number

To find this study again later, copy and save the study number:

Interested in more than one study? Log in to your ForPatients account to bookmark studies and get updates.

Talk to a doctor or nurse

To see if this study is a good fit, talk to your doctor or nurse you trust.

Together, you can look at the For Medical Professional tab and look into your medical history.

Reach out for more info

Some medical centers in this study offer a contact line. Click "Find participating medical centers" in the map below.

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

Basic Details

Sponsor Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland)

Phase Phase 1

Study Identifier GA43010, 2021-002464-48

Condition Asthma

Official Title A phase 1, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of single and multiple ascending doses of GDC-6599 and the effect of food on the pharmacokinetics and pharmacodynamics of GDC-6599 in healthy adult subjects

Study Summary

This clinical trial was done to study a new medicine, “GDC-6599,” for the treatment of people with asthma. This study was done to look at side effects at different doses and learn about whether this medicine was safe and could be tolerated by people. Researchers also wanted to learn about the effect of food on this medicine and whether it had any effect on the cell structure it was targeting. This was a phase 1, placebo-controlled, randomized, double-blind, dose-escalation study that was conducted at one study center in the Netherlands.

Eligibility Criteria

Gender

All

Age

18 to 75 Years

Healthy Volunteers

Yes

Inclusion Criteria

Signed Informed Consent Form
Age 18*75 years at time of signing Informed Consent Form
Ability to comply with the study protocol, in the investigator*s judgment
Body mass index of 18*30 kg/m2 at screening
Veins suitable for venipuncture and/or cannula insertion to accommodate blood sample collection at multiple timepoints during the study

Exclusion Criteria

Pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days after the final dose of study drug during the SAD/FE stage and for 28 days after the final dose of study drug during the MAD stage, unless a longer period is required by local regulations or ethics committee
Women must have a negative serum pregnancy test result within 1 day prior to initiation of study drug.
History of easy bruising or bleeding (i.e., bruising or bleeding out of
proportion to the degree of trauma)
Use of anticoagulant or anti-platelet therapies
History of significant hepatic impairment, defined as Child-Pugh Class B or C, corresponding to a Child-Turcotte-Pugh Score >= 7
History of abuse, in the investigator's judgment, of drugs including, but not limited to the following: amphetamines, barbiturates, benzodiazepines, cocaine, marijuana/cannabis, methadone, methamphetamine, ecstasy, morphine/opiates, phencyclidine, and tricyclic antidepressants within 12 months prior to screening and clinic admission
A positive drug screen test for any of the drugs listed above at screening is exclusionary.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study of a new medicine for asthma and cough: GDC-6599, a TRPA1 inhibitor

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

LPS GA43010 Final Results September 2024 English (PDF, 0.3 MB)

LPS GA43010 Final Results September 2024 Netherlands Dutch (PDF, 0.3 MB)

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

Directly contact Roche for questions

Contact the hospital directly

Thank you

Something went wrong

Request a call back

Find participating medical centers and current study status in each of them

A study of a new medicine for asthma and cough: GDC-6599, a TRPA1 inhibitor

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com