- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522506
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
A Phase 1b, 4-Period Crossover, Placebo-Controlled, Randomized, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-925 in Sleep-Deprived Healthy Adults Utilizing Modafinil as an Active Comparator
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The drug being tested in this study is called TAK-925. This study will assess the safety, tolerability, PK and PD of TAK-925 and will assess the effects of TAK-925 in sleep-deprived healthy adult participants.
The study will enroll approximately 20 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 4 treatment sequences-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- TAK-925 Low Dose + Placebo + TAK-925 High Dose + Modafinil
- TAK-925 High Dose + TAK-925 Low Dose + Modafinil + Placebo
- Modafinil+ TAK-925 High Dose + Placebo + TAK-925 Low Dose
- Placebo + Modafinil + TAK-925 Low Dose + TAK-925 High Dose
TAK-925 will be administered as an intravenous infusion based on the availability of safety, tolerability and PK data from health Japanese participants in ongoing study TAK-925-1001.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 10 weeks. Participants will make a final visit 7 days after receiving their last dose of drug for a follow-up assessment.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84124
- PRA Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TAK-925 Low Dose + Placebo + TAK-925 High Dose + Modafinil
TAK-925 low dose milligram (mg), intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001.
|
TAK-925 intravenous infusion.
TAK-925 placebo-matching given as saline intravenous infusion.
Modafinil tablets.
Modafinil placebo-matching tablet.
|
Experimental: TAK-925 High Dose + TAK-925 Low Dose + Modafinil + Placebo
TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 low dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001.
|
TAK-925 intravenous infusion.
TAK-925 placebo-matching given as saline intravenous infusion.
Modafinil tablets.
Modafinil placebo-matching tablet.
|
Experimental: Modafinil + TAK-925 High Dose + Placebo + TAK-925 Low Dose
Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 low dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001.
|
TAK-925 intravenous infusion.
TAK-925 placebo-matching given as saline intravenous infusion.
Modafinil tablets.
Modafinil placebo-matching tablet.
|
Experimental: Placebo + Modafinil + TAK-925 Low Dose + TAK-925 High Dose
Placebo, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 low dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001.
|
TAK-925 intravenous infusion.
TAK-925 placebo-matching given as saline intravenous infusion.
Modafinil tablets.
Modafinil placebo-matching tablet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start
Time Frame: 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.
|
Day 1: 2 hours post-infusion start
|
Latency to Sleep Onset on MWT at 4 Hours Post-infusion Start
Time Frame: 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.
|
Day 1: 4 hours post-infusion start
|
Latency to Sleep Onset on MWT at 6 Hours Post-infusion Start
Time Frame: 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.
|
Day 1: 6 hours post-infusion start
|
Latency to Sleep Onset on MWT at 8 Hours Post-infusion Start
Time Frame: 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.
|
Day 1: 8 hours post-infusion start
|
Latency to Sleep Onset on MWT at 1 Hour Post-end of Infusion
Time Frame: 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.
|
Day 1: 1 hour post-end of infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M-I and M-II
Time Frame: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M-I and M-II
Time Frame: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
|
Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-925 and Its Metabolites M-I and M-II
Time Frame: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M-I and M-II
Time Frame: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
|
T1/2z: Terminal Disposition Phase Half-life for TAK-925 and Its Metabolites M-I and M-II
Time Frame: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
|
CL: Total Clearance After Intravenous Administration for TAK-925
Time Frame: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
|
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-925
Time Frame: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
|
Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925
Time Frame: Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose
|
|
Sleepiness on KSS
Time Frame: Day 1: 14, 10, 6, 2 hours pre-infusion; 2.75, 4.75, 6.75. 8.75 hours post-infusion start; 1.75 hours post-infusion end
|
The KSS scale measures the subjective level of sleepiness at a particular time during the day.
On this scale participants indicate which level best reflects the psycho-physical state experienced in the last 10 minutes.
The KSS is a 9-item Likert-type rating scale for assessing subjective sleepiness, where 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep).
Lower score indicates more alertness.
|
Day 1: 14, 10, 6, 2 hours pre-infusion; 2.75, 4.75, 6.75. 8.75 hours post-infusion start; 1.75 hours post-infusion end
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAK-925-1002
- U1111-1211-2133 (Other Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on TAK-925
-
Millennium Pharmaceuticals, Inc.CompletedA Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic HypersomniaIdiopathic HypersomniaUnited States, Japan
-
TakedaCompletedHealthy Participants and Patients With NarcolepsyJapan
-
Millennium Pharmaceuticals, Inc.Completed
-
TakedaCompletedHealthy Participants | NarcolepsyJapan
-
TakedaCompleted
-
TakedaRecruiting
-
AbbottTerminatedSchizophreniaUnited States, Argentina, Mexico
-
Telios Pharma, Inc.RecruitingDry Eye DiseaseUnited States
-
Telios Pharma, Inc.Completed
-
Telios Pharma, Inc.Recruiting