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

  • Respiratory Disorder
  • Asthma
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Country
  • Netherlands
Trial Identifier:

2021-002464-48 GA43010

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

      Results Disclaimer

      Trial 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.

      Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland) Sponsor
      Phase 1 Phase
      GA43010, 2021-002464-48 Trial Identifier
      All Gender
      18 to 75 Years Age
      Yes Healthy Volunteers

      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.

      Trial 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.

      Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland) Sponsor
      Phase 1 Phase
      GA43010, 2021-002464-48 Trial Identifier
      GDC-6599 Treatments
      Asthma Condition
      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

      Eligibility Criteria

      All Gender
      18 to 75 Years Age
      Yes Healthy Volunteers
      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.

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

       

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