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

First listed
Dec 18, 2024
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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