Completed PHASE1 INTERVENTIONAL 3-arm NCT02215499

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

A Double-Blind, Phase 1, Single-Center, Single-Ascending Dose Study of JZP-386 Compared to Xyrem® vs. Placebo to Evaluate the Safety and Pharmacokinetics

Sponsor: Concert Pharmaceuticals

Conditions Narcolepsy, Excessive Daytime Sleepiness

Interventions JZP-386 Placebo Sodium Oxybate

Updated 6 times since 2017 Last updated: May 28, 2015 Started: Jul 31, 2014 Primary completion: Nov 30, 2014 Completion: Nov 30, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02215499, this PHASE1 trial focuses on Narcolepsy, Excessive Daytime Sleepiness and remains completed. Sponsored by Concert Pharmaceuticals, it has been updated 6 times since 2014, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Jul 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Concert Pharmaceuticals

Data source: Concert Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Ruddington, United Kingdom