Learn about Research & Clinical Trials
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||40 Years and Over|
- - IPF diagnosis based upon American Thoracic Association, Japanese Respiratory Society, European Respiratory Society, Latin American Thoracic Association guidelines within the last 7 years.
- - Ability to successfully perform lung function tests.
- - Subjects are willing to remain on study treatment for the duration of the study.
- - Subjects have a full understanding of the informed consent.
- - Evidence of other known causes of interstitial lung disease (ILD) (e.g., domestic, and occupational environmental exposures, connective tissue disease [CTD], and drug toxicity), lung transplant expected within 12 months of screening or evidence of clinically significant lung disease other than IPF including but not limited to asthma, chronic obstructive pulmonary disease (COPD), uncontrolled pulmonary hypertension and emphysema where computed tomography (CT)-assessed extent of emphysema is greater than extent of fibrosis.
- - History of malignancy, including carcinoma during the preceding 5 years.
- - Current use of supplemental oxygen for any condition.
- - Smoking within 6 months of study start, current smoker, or unwillingness to refrain from smoking during the clinical trial duration.
- - Presence of active infection at study start or confirmed active human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
- - Occurrence of serious illness requiring hospitalization within 90 days prior to study start.
- - Current or previous use (within 30 days prior to study start) of the following: 1.
- - Regular use of phosphodiesterase type-5 inhibitor, occasional use for erectile dysfunction will be allowed.
- - Use of drugs that are known moderate or stronger CYP3A4 inhibitors or inducers within 12 days prior to study start.
- - Males and females of reproductive potential who are sexually active and unwilling to use birth control for the duration of the study and for 3 months after their final dose.
- - Females that are pregnant or nursing.
- - Females and males that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final study dose.
- - Males who are unwilling to refrain from sperm donation and females who are unwilling to refrain from egg donation for the duration of the study and for 3 months after their final study dose.
- - Subjects with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of ENV-101.
- - Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study investigative site or the study Sponsor.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Endeavor Biomedicines, Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Srikanth Pendyala, M.D.|
|Principal Investigator Affiliation||Endeavor Biomedicines|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Canada, Korea, Republic of, Malaysia, Mexico|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Idiopathic Pulmonary Fibrosis|
taladegib, 200 mg tablet, once daily for 12 weeks
Placebo Comparator: placebo
placebo, tablet, once daily for 12 weeks
Drug: - taladegib
hedgehog pathway inhibitor dosed once daily
Drug: - placebo
identical tablets to the experimental arm with no active ingredient
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.