A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants
Recruiting
Phase 1
Interventional Study
Idiopathic Pulmonary Fibrosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 26 – 65
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 57 (estimated)
- Sponsor
- Endeavor Biomedicines, Inc. · Industry
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About This Trial
The purposes of this study are to:
1. evaluate potential interactions between taladegib (ENV-101) and current standard-of-care (SOC) therapies for idiopathic pulmonary fibrosis (IPF), including nintedanib and pirfenidone, and
2. more fully characterize the pharmacokinetics (PK) of taladegib (i.e., how the body absorbs, distributes, metabolizes and excretes taladegib).
This study will enroll 4 co…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participants are reproductively sterile.
* Body Mass Index (BMI) ≥ 18.5 and ≤ 32 kg/m2 and body weight ≥ 50 kg at study start.
* Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or electrocardiog…
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