Clinical Trials Logo
  1. Home
  2. Healthy Volunteers
  3. NCT05730842

Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:
A Phase 1, Open-label Study in Healthy Male Subjects of the Absorption, Metabolism, Excretion, and Pharmacokinetics of EDG-5506 and an Absolute Bioavailability Study Using Radiolabeled EDG-5506

Clinical Trial Summary

This is a Phase 1 2-part, single-center, open-label study in healthy male volunteers. Part A will assess the absorption, metabolism, excretion, and pharmacokinetics of one oral dose of radiolabeled EDG-5506. Part B will assess bioavailability of EDG-5506 with a single oral dose of EDG-5506 and a single intravenous dose of radiolabeled EDG-5506.

Clinical Trial Description

This is a Phase 1 2-part, single-center, open-label study. Up to 15 (8 in Part A and 7 in Part B) healthy male subjects will be enrolled in the study. Part A: Potential subjects will be screened to assess eligibility within 28 days prior to dose administration. Subjects will be admitted on Day -1 and confined to the study site until at least Day 30. On Day 1, subjects will receive a single oral suspension. Blood, urine and feces samples will be collected for determination of EDG-5506 concentration, total radioactivity, and metabolite profiling and identification. Between Day 30 and Day 36, subjects will be discharged. Part B: Potential subjects will be screened to assess their eligibility within 42 days prior to dose administration. Subjects will be admitted on Day -1 and confined to the study site until Day 8. On Day 1, subjects will receive a single oral dose of EDG-5506 in the fasted state followed 2 hours later by a single dose of radiolabeled EDG-5506. Subjects will be discharged from the study site on Day 8. Blood samples will be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05730842
Study type Interventional
Source Edgewise Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date January 12, 2023
Completion date April 6, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT06326723 - Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects Phase 1
Recruiting NCT00001367 - Diagnosis and History Study of Patients With Different Neurological Conditions
Completed NCT02699710 - Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects Phase 1
Completed NCT02231892 - Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study N/A
Not yet recruiting NCT06441916 - Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions Phase 1
Completed NCT03771586 - A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects Phase 1
Not yet recruiting NCT06337422 - Bioequivalence Study of Generic Celecoxib 200 mg Capsules Phase 1
Completed NCT03302182 - Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects Phase 1
Completed NCT05049343 - Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants Phase 1
Recruiting NCT01629108 - Normal Values in Hearing and Balance Testing
Completed NCT02947854 - Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant Phase 1
Completed NCT02534870 - Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects Phase 1
Completed NCT02224053 - Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers Phase 1
Completed NCT01711762 - A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers Phase 1
Completed NCT01676584 - A Study of Single Dose RO6811135 in Healthy Volunteers Phase 1
Completed NCT01697436 - A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets Phase 1
Completed NCT01684891 - A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers Phase 1
Completed NCT01591850 - A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers Phase 1
Completed NCT02547259 - Influence of Emotion in a Test Run Forgetfulness N/A
Completed NCT01461967 - A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers Phase 1