A study to look at how safe different doses of GDC-0334 were for healthy people and how this medicine was processed through the body

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

Healthy Volunteers

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Basic Details

Gender

All

Age

≥ 18 Years & ≤ 55 Years

Healthy Volunteers

Accepts Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT03381144, GB40223, 2017-003498-33

GDC-0334 is a new medicine for the treatment of patients with severe asthma. This study was the first time that humans got GDC-0334. People (healthy volunteers) received different doses of the study medicine to find out which dose was safe.

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

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

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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.

Phase Phase 1

Trial Identifier NCT03381144, GB40223, 2017-003498-33

Condition Healthy Volunteers

Official Title A Phase I, Randomised, Double-Blind, Placebo-Controlled, Single Centre, 3-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 Subjects

Study Summary

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.

Eligibility Criteria

Gender

All

Age

≥ 18 Years & ≤ 55 Years

Healthy Volunteers

Accepts Healthy Volunteers

Inclusion Criteria

Healthy males or non-pregnant, non-lactating healthy females. Females may be of non-childbearing potential or childbearing potential. Healthy females of childbearing potential must agree to use a highly effective method of contraception.
Healthy males must agree to use an adequate method of contraception
Body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m^2) or, if outside the range, considered not clinically significant by the investigator
Must be willing and able to communicate and participate in the whole study

Exclusion Criteria

Participants who have received any investigational medicinal product in a clinical research study within the previous 3 months
Participants who are study site employees, or immediate family members of a study site or sponsor employee
Participants who have previously been enrolled in this study. Participants who have enrolled in Part 1 are not permitted to enrol in Parts 2 or 3, and participants who have enrolled in Part 2 are not permitted to enroll in Part 3
History of any drug or alcohol abuse in the past 2 years
Regular alcohol consumption >14 units per week (1 unit = ½ pint beer, 25 milliliters (mL) of 40% spirit or a 125-mL glass of wine)
Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 6 parts per million (ppm) at screening or admission
Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator
Positive drugs-of-abuse test result at screening or admission
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) results
Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <70 milliliters per minute (mL/min) using the Cockcroft-Gault equation
History of seizure
History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder, as judged by the investigator
Participants with a history of cholecystectomy or gall stones (applies to any regimen where food effect is being explored)
History of serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Presence or history of active allergy requiring treatment, as judged by the investigator. History of hayfever is allowed unless it is active.
Donation or loss of greater than 400 mL of blood within the previous 3 months
Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days or 5 half-lives, whichever is longer, before investigational medicinal product administration. Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as agreed by the principal investigator and sponsor's medical monitor.
History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction, at screening or admission
QT interval corrected using Fridericia's formula (QTcF) > 450 milliseconds (msec) demonstrated by at least two ECGs >30 minutes apart
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease, coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome
Current treatment with medications that are well known to prolong the QT interval
History of dermatographism
Presence or history of clinically significant skin disorders, as judged by the investigator (Parts 1 and 3 only)
History of trauma or surgery (laceration repair is not excluded) to the arm but not including wrist or hand injury/surgery (Parts 1 and 3 only)
Failure to satisfy the investigator of fitness to participate for any other reason

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 to look at how safe different doses of GDC-0334 were for healthy people and how this medicine was processed through the body

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

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

Contact Genentech

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

A study to look at how safe different doses of GDC-0334 were for healthy people and how this medicine was processed through the body

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