A randomized phase 1 single-dose polysomnography study of ASP8062, a GABA_B receptor positive allosteric modulator.

ABSTRACT:

Rationale

Previous research suggests that sleep polysomnography and EEG endpoints can be used to assess GABAergic activity; however, the impact of GABA_B receptor positive allosteric modulators on sleep endpoints remains unclear.

Objectives

This phase 1 study compared a single dose of ASP8062 (35 mg or 70 mg), a GABA_B receptor positive allosteric modulator, with placebo and paroxetine (40 mg).

Methods

Healthy adult volunteers were randomized to four treatments (35 mg ASP8062, 70 mg ASP8062, paroxetine 40 mg, or matching placebo), each separated by a 14-day washout. Primary endpoints obtained by polysomnography were time in stage N3 or SWS and time in rapid eye movement (REM) sleep. Secondary endpoints included impact on sleep stages and electroenc

SUBMITTER: Walzer M 

PROVIDER: S-EPMC7914186 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature