Phase 1
Completed N=20
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
Healthy Volunteers
Source: ClinicalTrials.gov NCT03522506 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start — 15.68; 35.74; 40.02; 35.57 minute — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start |
15.68; 35.74; 40.02; 35.57 | <0.001 sig |
| PRIMARY Latency to Sleep Onset on MWT at 4 Hours Post-infusion Start |
9.10; 32.04; 40.05; 35.60 | <0.001 sig |
| PRIMARY Latency to Sleep Onset on MWT at 6 Hours Post-infusion Start |
6.15; 20.71; 38.36; 31.89 | <0.001 sig |
| PRIMARY Latency to Sleep Onset on MWT at 8 Hours Post-infusion Start |
3.53; 13.13; 36.86; 20.44 | 0.003 sig |
| PRIMARY Latency to Sleep Onset on MWT at 1 Hour Post-end of Infusion |
4.65; 2.49; 2.36; 21.42 | 0.436 |
| SECONDARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M-I and M-II |
940.4; 2303.7; 572.0; 1368.3; 12.3; 30.7 | — |
| SECONDARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M-I and M-II |
963.7; 2368.7; 586.8; 1405.6; 15.2; 32.0 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M-I and M-II |
105.8; 266.0; 61.9; 144.7; 1.3; 3.2 | — |
| SECONDARY Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-925 and Its Metabolites M-I and M-II |
103.4; 253.4; 64.0; 151.1; 1.5; 3.7 | — |
| SECONDARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M-I and M-II |
9.000; 9.000; 9.030; 9.000; 9.170; 9.000 | — |
| SECONDARY T1/2z: Terminal Disposition Phase Half-life for TAK-925 and Its Metabolites M-I and M-II |
3.134; 3.252; 2.424; 2.490; 2.235; 2.516 | — |
| SECONDARY CL: Total Clearance After Intravenous Administration for TAK-925 |
46.4; 47.6 | — |
| SECONDARY Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-925 |
207.4; 223.1 | — |
| SECONDARY Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925 |
106.7; 112.5 | — |
| SECONDARY Sleepiness on KSS |
3.05; 2.85; 3.29; 2.79; 2.50; 2.79 | 0.664 |
Eligibility Criteria
Inclusion Criteria
- Be a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before study drug administration of the initial dose of study drug.
- Have regular sleep-wake habits (example, routinely spending 6.5 to 8 hours sleeping nightly, not oversleeping by more than 3 hours on weekends, that is, total sleep not more than 11 hours) as determined by investigator interviews and confirmed in 5-day actigraphy records and whom regularly fall asleep between 9:30 PM and 12:00 AM.
- Be willing to have actigraphy monitoring during the week before randomization and in each interval.
Exclusion Criteria
- Has a positive alcohol or drug screen.
- Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer [354 milliliter per (mL/)12 ounces], wine (118 mL/4 ounces), or distilled spirits (29.5 mL/1 ounce)] per day).
- Has excessive sleepiness defined by a self-reported Epworth Sleepiness Scale score at screening greater than 10; irregular work hours; or routine night-shift work within 1 month before randomization.
- Currently experiencing or having a history of any known/suspected sleep disorder, any disorder associated with excessive daytime somnolence (EDS), or any diagnosis interfering with assessment of sleepiness.
- Abnormal findings on the initial polysomnography (PSG) conducted on Day -1 (check-in), as specified in the study manual.
- Traveled across 2 or more time zones 2 weeks or less before screening.
- Caffeine consumption of more than 400 milligram per day (mg/day) for 2 weeks before screening (1 serving of coffee is approximately equivalent to 120 mg of caffeine).
Data sourced from ClinicalTrials.gov (NCT03522506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.