Healthy ParticipantsPhase 1NCT03748979
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
A Phase 1 study testing TAK-925 in people with Healthy Participants and Narcolepsy, run by Takeda at 3 sites in Japan.
Trial summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Narcolepsy
- What is being tested?
- TAK-925
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 3 sitesJapan
- Study dates
- 21 Nov 2018to 24 Oct 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult participants and Healthy elderly participants:
- Participant weighs at least 50 kg (Healthy adults participants) / 40 kilogram (kg) (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kilogram per square meter (kg/m^2), inclusive at Screening.
- Narcolepsy participants:
- Participants weighs at least 40 kg inclusive at Screening (>=50 kg is required for Cohort B4).
- A diagnosis of narcolepsy, as defined by the International Classification of Sleep Disorders, Third Edition (ICSD-3).
- At Day -1, Epworth sleepiness scale (ESS) score >=10
Who cannot join
- All Participants:
- Participants consume excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
- Participants have a moderate to severe substance use disorder.
- Participants have a risk of suicide according to endorsement of item 4 or 5 with Screening/Baseline visit C-SSRS (Columbia Suicide Severity Rating Scale) or has made a suicide attempt in the previous 6 months.
- Participants have a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia.
- Participants experienced sleep wake cycle disturbance with external factors such as irregular work hours.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Hakata Clinic
Fukuoka
PS Clinic
Fukuoka
Sumida Hospital
Sumida-ku, Tokyo
About this study
Official title: A 3-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Patients With Narcolepsy
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants.
Read the detailed description
The drug being tested in this study is called TAK-925. TAK-925 is being tested in healthy participants and participants with narcolepsy. This study will look at the safety, tolerability, pharmacokinetics, and efficacy of TAK-925.
This study will consist of three parts. Part A will be a randomized, double-blind, placebo-controlled, multiple rising dose (MRD) study in healthy participants. Part B is a randomized, double-blind, placebo-controlled MRD study in participants with narcolepsy. Part C is a randomized, double-blind, placebo-controlled, parallel group, multiple repeat dose study in participants with narcolepsy. Part A' is a single dose study in healthy participants.
The study will enroll approximately 96 participants planned as total. All participants except Part A' will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):
Part A:
- TAK-925 (Dose Levels A1-A6)
- Placebo
Part B:
- TAK-925 (Dose Levels B1-B4)
- Placebo
Part C:
- TAK-925 (Dose Levels C1-C2)
- Placebo
Part A':
- TAK-925 (Dose Levels A'1-A'2)
All participants will be asked to take TAK-925 or Placebo at the same time each day from Day 1 to Day 7 in Parts A, B and C, and take TAK-925 on Day 1 in Part A'.
This multi-center trial will be conducted in Japan. The overall study period is approximately 15 days in Parts A, B and C, and approximately 7 days for Part A'. Participants will be partly admitted to a hospital during the study.
- Conditions
- Healthy Participants, Narcolepsy
- Being tested
- TAK-925, Placebo
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-925Drug
TAK-925
PlaceboDrug
TAK-925 Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1; TAK-925 (Dose Level A1) | Experimental | TAK-925, Dose Level A, once daily for up to 7 days in healthy participants. Receives: Drug: TAK-925 |
| Cohort A2; TAK-925 (Dose Level A2) | Experimental | TAK-925, Dose Level A2, once daily for up to 7 days in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. Receives: Drug: TAK-925 |
| Cohort A3; TAK-925 (Dose Level A3) | Experimental | TAK-925, Dose Level A3, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. Receives: Drug: TAK-925 |
| Cohort A4; TAK-925 (Dose Level A4) | Experimental | TAK-925, Dose Level A4, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. Receives: Drug: TAK-925 |
| Cohort A5; TAK-925 (Dose Level A5) | Experimental | TAK-925, Dose Level A5, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. Receives: Drug: TAK-925 |
| Cohort A6; TAK-925 (Dose Level A6) | Experimental | TAK-925, Dose Level A6, once daily for up to 7 days in healthy elderly participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. Receives: Drug: TAK-925 |
| Part A (Cohorts A1-A6); TAK-925 Placebo | Placebo comparator | TAK-925 Placebo, once daily for up to 7 days in healthy participants. Receives: Drug: Placebo |
| Cohort B1; TAK-925 (Dose Level B1) | Experimental | TAK-925, Dose Level B1, once daily for up to 7 days in participants with narcolepsy. Receives: Drug: TAK-925 |
| Cohort B2; TAK-925 (Dose Level B2) | Experimental | TAK-925, Dose Level B2, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. Receives: Drug: TAK-925 |
| Cohort B3; TAK-925 (Dose Level B3) | Experimental | TAK-925, Dose Level B3, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. Receives: Drug: TAK-925 |
| Cohort B4; TAK-925 (Dose Level B4) | Experimental | TAK-925, Dose Level B4, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. Receives: Drug: TAK-925 |
| Part B (Cohorts B1-B4); TAK-925 Placebo | Placebo comparator | TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy. Receives: Drug: Placebo |
| Cohort C1; TAK-925 (Dose Level C1) | Experimental | TAK-925, Dose Level C1, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. Receives: Drug: TAK-925 |
| Cohort C2; TAK-925 (Dose Level C2) | Experimental | TAK-925, Dose Level C2, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. Receives: Drug: TAK-925 |
| Part C (Cohorts C1-C2); TAK-925 Placebo | Placebo comparator | TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy. Receives: Drug: Placebo |
| Cohort A'1; TAK-925 (Dose Level A'1) | Experimental | TAK-925, Dose Level A'1, single dose in healthy participants. Receives: Drug: TAK-925 |
| Cohort A'2; TAK-925 (Dose Level A'2) | Experimental | TAK-925, Dose Level A'2, single dose in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. Receives: Drug: TAK-925 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.
Measured: From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)
Secondary outcomes (4)
Parts A, B and C; Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925
This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures.
Measured: Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf
Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve During a Dosing Interval for TAK-925
This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures.
Measured: Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf
Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925
Accumulation Ratio of AUC was calculated as AUCtau on Day 7 divided by AUCtau on Day 1. This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures.
Measured: Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf
Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7
The MWT is a validated objective measure that is used to measure excessive daytime sleepiness in clinical studies. It has been used as a secondary outcome measure for excessive daytime sleepiness. The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Wakefulness in this study was measured indirectly by time to fall asleep using MWT. In this study, four 40-minute (1 session) MWT assessments per day was administered on Baseline, Day 1 and Day 7. MWT sleep latency ranges from 0 to 40 minutes, with longer sleep latency indicating greater ability to stay awake.
Measured: Baseline, Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start21 Nov 2018
- Primary completion24 Oct 2019
- Study completion24 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748979
- Sponsor's protocol ID
- TAK-925-1003
- Other IDs
- U1111-1221-3144, JapicCTI-184207
- Status last verified
- Dec 2020
- First submitted
- 15 Nov 2018
- Last updated
- 8 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Patients With Narcolepsy
- ClinicalTrials.gov ID
- NCT03748979
- Acronym / sponsor ID
- TAK-925-1003
- Conditions
- Healthy Participants, Narcolepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 24 Oct 2019 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Posted 8 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants.
Detailed description
The drug being tested in this study is called TAK-925. TAK-925 is being tested in healthy participants and participants with narcolepsy. This study will look at the safety, tolerability, pharmacokinetics, and efficacy of TAK-925.
This study will consist of three parts. Part A will be a randomized, double-blind, placebo-controlled, multiple rising dose (MRD) study in healthy participants. Part B is a randomized, double-blind, placebo-controlled MRD study in participants with narcolepsy. Part C is a randomized, double-blind, placebo-controlled, parallel group, multiple repeat dose study in participants with narcolepsy. Part A' is a single dose study in healthy participants.
The study will enroll approximately 96 participants planned as total. All participants except Part A' will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):
Part A:
- TAK-925 (Dose Levels A1-A6)
- Placebo
Part B:
- TAK-925 (Dose Levels B1-B4)
- Placebo
Part C:
- TAK-925 (Dose Levels C1-C2)
- Placebo
Part A':
- TAK-925 (Dose Levels A'1-A'2)
All participants will be asked to take TAK-925 or Placebo at the same time each day from Day 1 to Day 7 in Parts A, B and C, and take TAK-925 on Day 1 in Part A'.
This multi-center trial will be conducted in Japan. The overall study period is approximately 15 days in Parts A, B and C, and approximately 7 days for Part A'. Participants will be partly admitted to a hospital during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Cohort A1; TAK-925 (Dose Level A1) | Experimental | Drug: TAK-925TAK-925, Dose Level A, once daily for up to 7 days in healthy participants. |
| Cohort A2; TAK-925 (Dose Level A2) | Experimental | Drug: TAK-925TAK-925, Dose Level A2, once daily for up to 7 days in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A3; TAK-925 (Dose Level A3) | Experimental | Drug: TAK-925TAK-925, Dose Level A3, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A4; TAK-925 (Dose Level A4) | Experimental | Drug: TAK-925TAK-925, Dose Level A4, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A5; TAK-925 (Dose Level A5) | Experimental | Drug: TAK-925TAK-925, Dose Level A5, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A6; TAK-925 (Dose Level A6) | Experimental | Drug: TAK-925TAK-925, Dose Level A6, once daily for up to 7 days in healthy elderly participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Part A (Cohorts A1-A6); TAK-925 Placebo | Placebo comparator | Drug: PlaceboTAK-925 Placebo, once daily for up to 7 days in healthy participants. |
| Cohort B1; TAK-925 (Dose Level B1) | Experimental | Drug: TAK-925TAK-925, Dose Level B1, once daily for up to 7 days in participants with narcolepsy. |
| Cohort B2; TAK-925 (Dose Level B2) | Experimental | Drug: TAK-925TAK-925, Dose Level B2, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort B3; TAK-925 (Dose Level B3) | Experimental | Drug: TAK-925TAK-925, Dose Level B3, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort B4; TAK-925 (Dose Level B4) | Experimental | Drug: TAK-925TAK-925, Dose Level B4, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Part B (Cohorts B1-B4); TAK-925 Placebo | Placebo comparator | Drug: PlaceboTAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy. |
| Cohort C1; TAK-925 (Dose Level C1) | Experimental | Drug: TAK-925TAK-925, Dose Level C1, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort C2; TAK-925 (Dose Level C2) | Experimental | Drug: TAK-925TAK-925, Dose Level C2, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Part C (Cohorts C1-C2); TAK-925 Placebo | Placebo comparator | Drug: PlaceboTAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy. |
| Cohort A'1; TAK-925 (Dose Level A'1) | Experimental | Drug: TAK-925TAK-925, Dose Level A'1, single dose in healthy participants. |
| Cohort A'2; TAK-925 (Dose Level A'2) | Experimental | Drug: TAK-925TAK-925, Dose Level A'2, single dose in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant weighs at least 50 kg (Healthy adults participants) / 40 kilogram (kg) (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kilogram per square meter (kg/m^2), inclusive at Screening.
- Participants weighs at least 40 kg inclusive at Screening (>=50 kg is required for Cohort B4).
- A diagnosis of narcolepsy, as defined by the International Classification of Sleep Disorders, Third Edition (ICSD-3).
- At Day -1, Epworth sleepiness scale (ESS) score >=10
Key exclusion criteria (6 listed)
- Participants consume excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
- Participants have a moderate to severe substance use disorder.
- Participants have a risk of suicide according to endorsement of item 4 or 5 with Screening/Baseline visit C-SSRS (Columbia Suicide Severity Rating Scale) or has made a suicide attempt in the previous 6 months.
- Participants have a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia.
- Participants experienced sleep wake cycle disturbance with external factors such as irregular work hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-925TAK-925 | Drug | Cohort A'1; TAK-925 (Dose Level A'1), Cohort A'2; TAK-925 (Dose Level A'2), Cohort A1; TAK-925 (Dose Level A1), Cohort A2; TAK-925 (Dose Level A2), Cohort A3; TAK-925 (Dose Level A3), Cohort A4; TAK-925 (Dose Level A4), Cohort A5; TAK-925 (Dose Level A5), Cohort A6; TAK-925 (Dose Level A6), Cohort B1; TAK-925 (Dose Level B1), Cohort B2; TAK-925 (Dose Level B2), Cohort B3; TAK-925 (Dose Level B3), Cohort B4; TAK-925 (Dose Level B4), Cohort C1; TAK-925 (Dose Level C1), Cohort C2; TAK-925 (Dose Level C2) |
| PlaceboTAK-925 Placebo | Drug | Part A (Cohorts A1-A6); TAK-925 Placebo, Part B (Cohorts B1-B4); TAK-925 Placebo, Part C (Cohorts C1-C2); TAK-925 Placebo |
Primary outcome
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.
4 secondary outcomes
Parts A, B and C; Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925
Time frame: Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf
Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve During a Dosing Interval for TAK-925
Time frame: Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf
Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925
Time frame: Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf
Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7
Time frame: Baseline, Day 1 and Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-925 in people with Healthy Participants and Narcolepsy, run by Takeda at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) (time frame: From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.