A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics (PK) of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to assess the safety and tolerability of TAK-994 and to determine the effect of TAK-994 (compared to placebo) on sleepiness, as measured by mean sleep latency on the maintenance of wakefulness Test (MWT), in an acute sleep phase delay paradigm in healthy participants.

Key facts

Study ID

NCT04551079

Run by

Takeda

People needed

19

Starts

2020-09-23

Expected to finish

2020-12-31

Last updated by the study team

2021-01-19

Who can join

Age: 18 and older, up to 40. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Be a current nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months prior to the first dose of study drug.
• Have regular sleep-wake habits (example, routinely spending 6.5 to 8 hour sleeping nightly, not oversleeping by more than 3 hour on weekends [that is, total sleep not more than 11 hour]) as determined by investigator interviews and confirmed in 5-day actigraphy records and regularly fall asleep between 9:30 PM and 12:00 AM.

You may not qualify if…

• Have a positive alcohol or drug screen or a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per day).
• Have excessive sleepiness, defined by a self-reported Epworth Sleepiness Scale (ESS) score at screening greater than (>) 10; irregular work hours; or routine night-shift work within 1 month before randomization.
• Have a prior history of or currently is experiencing any known/suspected sleep disorder (including obstructive sleep apnea and restless leg syndrome), any disorder associated with excessive daytime sleepiness (EDS), or any diagnosis interfering with assessment of sleepiness.
• At the time of screening, be receiving treatment with nasal/oronasal positive airway pressure for any reason.
• Have abnormal findings on the initial polysomnography conducted on Day -1 (check-in) of the first treatment period.
• Have traveled across 2 or more time zones within the 2 weeks before screening.
• Have caffeine consumption of more than 400 milligram (mg)/day for 2 weeks before screening (1 serving of coffee is approximately equivalent to 120 mg of caffeine).

Where it is running

• Clinilabs Drug Development Corporation — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.