A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants

Sponsor
Endeavor Biomedicines, Inc.
Study ID
NCT07454291
Phase
PHASE1
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
26 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • taladegib — DRUG
    low, medium or high dose tablet administered once, or once a day
  • nintedanib — DRUG
    150 mg capsule administered twice a day
  • pirfenidone — DRUG
    One, two or three 267 mg tablets administered three times a day
  • pirfenidone — DRUG
    Three 267 mg tablets administered once

Study Details

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 cohorts (groups) of participants. Each cohort will experience a different duration of treatment and sequestering (being housed) at the clinical site, followed by a 14-day follow-up period for safety evaluation. The longest duration of treatment for any cohort is 30 days.

Key Dates

First listed
Mar 6, 2026
Start date
Apr 28, 2026
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
57 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (effect of nintedanib on taladegib pharmacokinetics)
    This cohort will receive multiple days of nintedanib twice a day to see its effect on a single dose of taladegib.
  • Experimental: Cohort 2 (effect of pirfenidone on taladegib pharmacokinetics)
    This cohort will receive multiple days of pirfenidone three times a day to see its effect on a single dose of taladegib.
  • Experimental: Cohort 3 (effect of taladegib on pirfenidone pharmacokinetics)
    This cohort will receive multiple days of taladegib once a day to see its effect on a single dose of pirfenidone.
  • Experimental: Cohort 4 (measure taladegib pharmacokinetics)
    This cohort will receive a single dose of taladegib to measure its pharmacokinetic profile.

Primary Outcome Measure

Cohort 1: Taladegib (ENV-101) maximum blood concentration (Cmax) after administration alone and after coadministration with nintedanib [ Time Frame: Day 1 and Day 13 ]

Central Contacts

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