A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants with Narcolepsy

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224146

Enrollment

Registered

2018-11-16

Start date

2018-11-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants and Patients with Narcolepsy

Interventions

investigational material(s) Generic name etc : TAK-925 INN of investigational material : - Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational material :

TAK-925, once daily for up to 7 days in healthy participants (or healthy elderly participants). Cohorts A3-A6 are additional optional cohorts and dose levels will be determined based on the data of sa

TAK-925, once daily for up to 7 days in patients with narcolepsy. Cohorts B3-B4 are additional optional cohorts and dose levels will be determined based on the data of safety, tolerability and PK data

TAK-925, once daily for up to 7 days in patients with narcolepsy. Cohort C2 is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data fro

TAK-925, single dose in healthy participants. Cohort A'2 is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy adult participants and Healthy elderly participants: - Participant weighs at least 50 kg (Healthy adults participants) / 40 kg (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kg/m^2, inclusive at Screening. Narcolepsy patients: - Patient 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

Exclusion criteria

Exclusion criteria: 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 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.

Design outcomes

Primary

Measure	Time frame
safety Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) Timeframe; From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)	—

Secondary

Measure	Time frame
pharmacokinetics Parts A, B and C; Ceoi:Observed Plasma Concentration at the End of Infusion for TAK-925 Timeframe; 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 pharmacokinetics Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve during a Dosing Interval for TAK-925 Timeframe; 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 pharmacokinetics Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925 Timeframe; 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 Accumulation Ratio of AUC was calculated as AUCtau on Day 7 divided by AUCtau on Day 1. efficacy Parts B and C: Change from Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7 Timeframe; Baseline,Day 1 and to Day 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.	—

Measure

Time frame

pharmacokinetics Parts A, B and C; Ceoi:Observed Plasma Concentration at the End of Infusion for TAK-925 Timeframe; 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 pharmacokinetics Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve during a Dosing Interval for TAK-925 Timeframe; 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 pharmacokinetics Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925 Timeframe; 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 Accumulation Ratio of AUC was calculated as AUCtau on Day 7 divided by AUCtau on Day 1. efficacy Parts B and C: Change from Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7 Timeframe; Baseline,Day 1 and to Day 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.

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026