A Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Edgewise Therapeutics, Inc.
Study ID
NCT06738836
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to: 1. Assess the mass balance (i.e., the cumulative elimination of 14C-related material in urine and feces, compared to the administered amount of radioactive isotope) of \[14C\]-EDG-7500 following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects. 2. Characterize the pharmacokinetics of EDG-7500 in plasma and of 14C-related material in whole blood, plasma, urine and feces following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.

Key Dates

Start date
Dec 3, 2024
Status verified
Apr 2025
Primary completion
Jan 17, 2025
Completion
Jan 17, 2025

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Human AME

Primary Outcome Measure

Mass Balance [ Time Frame: From Day -1 through study completion (up to 19 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Pharmaron Clinical Pharmacology Center, Inc.BaltimoreMaryland21201-

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By research site
Pharmaron Clinical Pharmacology Center, Inc.· Baltimore, MD

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