drugset / Trial / NCT03637361

Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of REL-1017 (d-Methadone)

NCT03637361 ↗

Phase 1 Completed 42 enrolled Relmada Therapeutics, Inc.
RandomizedParallel-groupDouble-blindBasic science

Summary

This study evaluated the safety, tolerance, and pharmacokinetics (PK) of d-methadone in a limited dose range, in single administrations in humans.

Timeline

Start
2014-12-04
Primary completion
2015-06-02
Completion
2015-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Esmethadone Small molecule 5 mg Oral
Subject Esmethadone Small molecule 20 mg Oral
Subject Esmethadone Small molecule 60 mg Oral
Subject Esmethadone Small molecule 100 mg Oral
Subject Esmethadone Small molecule 150 mg Oral
Subject Esmethadone Small molecule 200 mg Oral

Indications