Trial · NCT03522506
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
NCT03522506, Phase 1, Completed, Takeda; results first posted 2019-11-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults. Trials, record NCT03522506. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03522506
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
- NCT number
- NCT03522506
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Healthy Volunteers
- Interventions
- TAK-925, TAK-925 Placebo, Modafinil, Modafinil Placebo
- First posted
- 2018-05-11
- Last updated
- 2021-03-26
- Results first posted
- 2019-11-26
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start | Day 1: 2 hours post-infusion start | The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake. |
| Primary | Latency to Sleep Onset on MWT at 4 Hours Post-infusion Start | Day 1: 4 hours post-infusion start | The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake. |
| Primary | Latency to Sleep Onset on MWT at 6 Hours Post-infusion Start | Day 1: 6 hours post-infusion start | The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake. |
| Primary | Latency to Sleep Onset on MWT at 8 Hours Post-infusion Start | Day 1: 8 hours post-infusion start | The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake. |
| Primary | Latency to Sleep Onset on MWT at 1 Hour Post-end of Infusion | Day 1: 1 hour post-end of infusion | The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake. |
| 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 | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | |
| 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 | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | |
| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M-I and M-II | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | |
| Secondary | Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-925 and Its Metabolites M-I and M-II | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | |
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M-I and M-II | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start | Day 1: 2 hours post-infusion start | Pharmacodynamics (PD) analysis set: all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from MWT, polysomnography (PSG), Karolinska Sleepiness Scale (KSS), or Cambridge Cognition Computerized Battery of Tests (CCBT). PD analysis set where data at specified time points was available. | minute | LEAST_SQUARES_MEAN |
| 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 | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | The pharmacokinetic (PK) analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. | hour*nanogram per milliliter (h*ng/mL) | MEAN |
| 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 | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. The PK analysis set where data at specified time points was available. | h*ng/mL | MEAN |
| SECONDARY | Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M-I and M-II | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-925 and Its Metabolites M-I and M-II | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. | ng/mL | MEAN |
| SECONDARY | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M-I and M-II | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. | hour | MEDIAN |
| SECONDARY | T1/2z: Terminal Disposition Phase Half-life for TAK-925 and Its Metabolites M-I and M-II | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. The PK analysis set where data at specified time points was available. | hour | MEAN |
| SECONDARY | CL: Total Clearance After Intravenous Administration for TAK-925 | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. | liter per hour (L/h) | MEAN |
| SECONDARY | Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-925 | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. | liter | MEAN |
| SECONDARY | Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925 | Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose | The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. | liter | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start | Placebo | 15.68 | Standard Error 2.305 | minute | |
| Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start | TAK-925 44 mg | 35.74 | Standard Error 2.445 | minute | |
| Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start | TAK-925 112 mg | 40.02 | Standard Error 2.445 | minute | |
| Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start | Modafinil 300 mg | 35.57 | Standard Error 2.368 | minute | |
| 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 | TAK-925 44 mg | TAK-925 | 940.4 | Standard Deviation 127.26 | hour*nanogram per milliliter (h*ng/mL) |
| 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 | TAK-925 112 mg | TAK-925 | 2303.7 | Standard Deviation 174.23 | hour*nanogram per milliliter (h*ng/mL) |
| 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 | TAK-925 44 mg | M-I | 572.0 | Standard Deviation 196.75 | hour*nanogram per milliliter (h*ng/mL) |
| 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 | TAK-925 112 mg | M-I | 1368.3 | Standard Deviation 489.96 | hour*nanogram per milliliter (h*ng/mL) |
| 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 | TAK-925 44 mg | M-II | 12.3 | Standard Deviation 7.91 | hour*nanogram per milliliter (h*ng/mL) |
| 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 | TAK-925 112 mg | M-II | 30.7 | Standard Deviation 19.39 | hour*nanogram per milliliter (h*ng/mL) |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow84
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (2 Days) | STARTED | TAK-925 44 mg + Placebo + TAK-925 112 mg + Modafinil 300 mg | 5 | |
| Treatment Period 1 (2 Days) | STARTED | TAK-925 112 mg + TAK-925 44 mg + Modafinil 300 mg + Placebo | 5 | |
| Treatment Period 1 (2 Days) | STARTED | Modafinil 300 mg + TAK-925 112 mg + Placebo + TAK-925 44 mg | 5 | |
| Treatment Period 1 (2 Days) | STARTED | Placebo + Modafinil 300 mg + TAK-925 44 mg + TAK-925 112 mg | 5 | |
| Treatment Period 1 (2 Days) | COMPLETED | TAK-925 44 mg + Placebo + TAK-925 112 mg + Modafinil 300 mg | 5 | |
| Treatment Period 1 (2 Days) | COMPLETED | TAK-925 112 mg + TAK-925 44 mg + Modafinil 300 mg + Placebo | 5 | |
| Treatment Period 1 (2 Days) | COMPLETED | Modafinil 300 mg + TAK-925 112 mg + Placebo + TAK-925 44 mg | 5 | |
| Treatment Period 1 (2 Days) | COMPLETED | Placebo + Modafinil 300 mg + TAK-925 44 mg + TAK-925 112 mg | 5 | |
| Treatment Period 1 (2 Days) | NOT COMPLETED | TAK-925 44 mg + Placebo + TAK-925 112 mg + Modafinil 300 mg | 0 | |
| Treatment Period 1 (2 Days) | NOT COMPLETED | TAK-925 112 mg + TAK-925 44 mg + Modafinil 300 mg + Placebo | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events156
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctivitis allergic | Eye disorders | Placebo | 1 | 20 | |
| other | Conjunctivitis allergic | Eye disorders | TAK-925 44 mg | 0 | 18 | |
| other | Conjunctivitis allergic | Eye disorders | TAK-925 112 mg | 0 | 18 | |
| other | Conjunctivitis allergic | Eye disorders | Modafinil 300 mg | 0 | 19 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 20 | |
| other | Nausea | Gastrointestinal disorders | TAK-925 44 mg | 0 | 18 | |
| other | Nausea | Gastrointestinal disorders | TAK-925 112 mg | 1 | 18 | |
| other | Nausea | Gastrointestinal disorders | Modafinil 300 mg | 3 | 19 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 20 | |
| other | Diarrhoea | Gastrointestinal disorders | TAK-925 44 mg | 0 | 18 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, all-cause mortality | TAK-925 44 mg | 0 | 18 |
| Total, all-cause mortality | TAK-925 112 mg | 0 | 18 |
| Total, all-cause mortality | Modafinil 300 mg | 0 | 19 |
| Total, other adverse events | Placebo | 4 | 20 |
| Total, other adverse events | TAK-925 44 mg | 5 | 18 |
| Total, other adverse events | TAK-925 112 mg | 11 | 18 |
| Total, other adverse events | Modafinil 300 mg | 11 | 19 |
| Total, serious adverse events | Placebo | 0 | 20 |
| Total, serious adverse events | TAK-925 44 mg | 0 | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36934366 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03522506
GET https://conductscience.org/api/trials/v1/NCT03522506/results?page=2