A Randomized, Double-blind, Placebo-controlled Crossover Study of the Pharmacodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Single Doses of HBS 104 in Acutely Sleep-deprived Healthy Participants

Harmony Biosciences Management, Inc.

Summary

This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants.

Description

Single oral doses of HBS-104 (low, medium or high doses) or matching placebo will be administered in 4 double-blind treatment periods in a crossover design. Each treatment period is 4 days in duration (Days -1 to 3) separated by a 7 to 12 day washout interval.

Eligibility

Age range: 18–55 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Provide written informed consent before any study-related procedures are performed. * Be healthy as determined by assessments at the Screening Visit. Exclusion Criteria: * Female with a positive pregnancy test at Screening Visit or upon check-in for Period 1. * Is currently breastfeeding or planning to breastfeed over the course of the study. Lactating women must agree not to breastfeed for the duration of the study and for 7 days after their final dose of study drug. Note: Additional inclusion/exclusion criteria may apply, per protocol

Interventions

Drug
HBS-104
Immediate-release tablets for oral use
Drug
Placebo
Matching placebo tablet

Location

Sponsor Clinical Site - New Jersey
Eatontown, New Jersey