Jazz Pharmaceuticals plc and Concert Pharmaceuticals Inc have initiated the first Phase 1 clinical trial of JZP-386. JZP-386 is a deuterium-containing analog of sodium oxybate—the active ingredient in Xyrem (sodium oxybate) oral solution.
The Phase 1 clinical trial is designed to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of JZP-386, and includes Xyrem as an active control. The study is expected to enroll up to 28 healthy subjects at a single center in Europe. The results of the study are intended to assess the PK/PD profile of JZP-386 to identify a safe and tolerable dose or doses of JZP-386 that could be used in subsequent clinical trials and to determine whether JZP-386 is suitable for once nightly dosing.
“Initiating this first-in-human Phase 1 study with JZP-386 is an important milestone in our development program and will provide valuable information on the potential benefit of this deuterium-containing analog of sodium oxybate. This study reflects our ongoing commitment to addressing the unmet medical needs of patients with narcolepsy and to further advancing our understanding of sodium oxybate.” says Jeffrey Tobias, MD, executive vice president and chief medical officer of Jazz Pharmaceuticals, in a release.
“We are pleased to see JZP-386 advancing to clinical evaluation under our collaboration with Jazz Pharmaceuticals. We look forward to evaluating JZP-386 and seeing the results from this first-in-human clinical trial,” said Roger Tung, PhD, president and CEO of Concert Pharmaceuticals.
Under its 2013 agreement with Concert, Jazz Pharmaceuticals has worldwide rights to develop and commercialize JZP-386. Concert has the potential to realize milestone payments upon meeting development objectives and tiered royalties on any worldwide sales. Jazz Pharmaceuticals and Concert are working collaboratively on development of JZP-386, and Concert is responsible for conducting clinical activities for JZP-386 through Phase 1.
Sodium oxybate is the active ingredient in Xyrem, a prescription medicine marketed in the United States by Jazz Pharmaceuticals to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy.