Phase 1
N=57
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
Healthy Participants · Narcolepsy
Bottom Line
View on ClinicalTrials.gov: NCT03748979 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) — 1; 0; 2; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TAK-925 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) |
1; 0; 2; 4; 1; 1 | — |
| SECONDARY Parts A, B and C; Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925 |
74.49; 166.9; 300.2; 17.39; 70.20; 68.74 | — |
| SECONDARY Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve During a Dosing Interval for TAK-925 |
662.4; 1516; 2615; 164.2; 682.3; 648.3 | — |
| SECONDARY Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925 |
0.9832; 1.009; 1.050; 1.118; 1.062; 1.017 | — |
| SECONDARY Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7 |
1.97; 2.03; 5.23; 4.13; 6.83; 7.33 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
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
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 (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.
Data sourced from ClinicalTrials.gov (NCT03748979). 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.