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A Drug-Drug Interaction Study of ENV-101 (Taladegib) on Nintedanib Pharmacokinetics in Healthy Subjects

NCT05817240 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-12-15

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about the potential effect of ENV-101 (taladegib) on the pharmacokinetics of nintedanib (an approved treatment for idiopathic pulmonary fibrosis) when the two compounds are dosed together in healthy subjects. Participants in this study will receive ENV-101 and/or nintedanib on various days throughout a 10-day period during which they will reside at the clinical trial site.

Conditions

Interventions

DRUG

taladegib

100 mg per tablet, dosed once daily

DRUG

nintedanib

100 mg per capsule, dosed once daily

Sponsors & Collaborators

  • Endeavor Biomedicines, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Frohna, M.D., Ph.D. · Endeavor Biomedicines

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-03
Primary Completion
2023-06-11
Completion
2023-06-21
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05817240 on ClinicalTrials.gov