A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults

Summary

The purpose of this study is to determine the effect of TAK-925 after a single intravenous dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the maintenance of wakefulness (MWT) in sleep-deprived healthy participants.

Timeline

Start

2018-05-09

Primary completion

2018-11-07

Completion

2018-11-07

Outcome

Mixed primary results

registry analysis (superiority test); Placebo vs TAK-925 44 mg; p <0.001; Least square mean difference 20.06 (95% CI 13.35 to 26.77); Linear mixed effect model NCT03522506 ↗

registry analysis (superiority test); Placebo vs TAK-925 44 mg; p = 0.436; LSM difference -2.16 (95% CI -7.68 to 3.36); ANOVA NCT03522506 ↗

Publications

• Evans R, Kimura H, Nakashima M, Ishikawa T, Yukitake H, Suzuki M, Hazel J, Faessel H, Wu J, Hang Y, Alexander R, Rosen L, Hartman DS, Ratti E. Orexin 2 receptor-selective agonist danavorexton (TAK-925) promotes wakefulness in non-human primates and healthy individuals. J Sleep Res. 2023 Oct;32(5):e13878. doi: 10.1111/jsr.13878. Epub 2023 Mar 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Danavorexton	Small molecule	44 mg	Intravenous
Subject	Danavorexton	Small molecule	112 mg	Intravenous
Subject	Modafinil	Small molecule	300 mg	Oral

Indications

No indication recorded.