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
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.
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. ;
| 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 |
NCT01697436 -
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
|
Phase 1 | |
| Completed |
NCT01676584 -
A Study of Single Dose RO6811135 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01711762 -
A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
|
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 |
NCT01414881 -
Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01579149 -
A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent
|
Phase 1 |