drugset / Trial / NCT02215499

A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics

NCT02215499

Phase 1 Completed 28 enrolled Concert Pharmaceuticals
RandomizedCrossoverQuadruple-blindBasic science

Summary

This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.

Timeline

Start
2014-07
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject JZP-386 Unknown Oral
Comparator Sodium Oxybate Unknown Oral

Indications