Phase 1 N=58 Randomized Double-blind Other

Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy

Healthy Participants and Patients With Narcolepsy

Bottom Line

View on ClinicalTrials.gov: NCT03332784 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) — 1; 1; 1; 1 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: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)	1; 1; 1; 1; 1; 1	—
PRIMARY Number of Participants Who Experience at Least One TEAE Related to Vital Signs	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants Who Experience at Least One TEAE Related to Body Weight	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants Who Experience at Least One TEAE Related to 12-lead Electrocardiogram (ECG)	0; 0; 0; 1; 0; 1	—
PRIMARY Number of Participants Who Experience at Least One TEAE Related to Clinical Laboratory Tests	1; 0; 0; 0; 1; 0	—
PRIMARY Part 1, 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 M1 and M2	138.0; 323.1; 513.3; 1055; 2069; 2655	—
PRIMARY Part 2, 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 M1 and M2	910.8; 198.7; 86.15; 623.6; 100.7; 52.25	—
PRIMARY Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2	141.8; 328.1; 523.5; 1065; 2092; 2682	—
PRIMARY Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M1 and M2	925.3; 200.7; 88.45; 634.0; 102.4; 54.77	—
PRIMARY Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2	16.70; 36.83; 57.56; 122.6; 235.2; 304.9	—
PRIMARY Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M1 and M2	96.48; 21.86; 10.10; 64.28; 11.23; 5.990	—
PRIMARY Part 1, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2	13.37; 29.81; 52.08; 114.6; 213.8; 290.3	—
PRIMARY Part 2, Ceoi: Concentration at the End of Infusion for TAK-925 and Its Metabolites M1 and M2	94.04; 21.17; 9.649; 58.61; 9.916; 5.412	—
PRIMARY Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2	3.000; 4.000; 3.000; 4.000; 4.000; 6.500	—
PRIMARY Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M1 and M2	6.500; 9.000; 9.000; 6.000; 6.000; 6.000	—
PRIMARY Part 1, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2	4.120; 4.498; 5.142; 3.860; 3.788; 3.943	—
PRIMARY Part 2, t1/2z: Terminal Disposition Phase Half-life of TAK-925 and Its Metabolites M1 and M2	4.130; 3.923; 3.465; 3.670; 2.523; 2.154	—
PRIMARY Part 1, Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925	82.88; 77.07; 116.1; 91.40; 97.83; 88.47	—
PRIMARY Part 2, Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925	116.8; 114.1; 111.7	—
PRIMARY Part 1, Vz: Volume of Distribution During the Terminal Phase After Intravenous Administration for TAK-925	292.2; 271.7; 391.8; 290.7; 288.8; 284.7	—
PRIMARY Part 2, Vz: Volume of Distribution During the Terminal Phase After Intravenous Administration for TAK-925	281.3; 316.8; 282.3	—
PRIMARY Part 1, CL: Total Clearance After Intravenous Administration for TAK-925	50.00; 43.07; 54.20; 53.10; 54.10; 50.90	—
PRIMARY Part 2, CL: Total Clearance After Intravenous Administration for TAK-925	50.18; 55.90; 57.05	—
PRIMARY Part 1, Ae(0-24): Amount of TAK-925 and Its Metabolites M1 and M2 Excreted in Urine From Time 0 to Time 24	1.892; 5.460; 14.10; 60.87; 210.5; 335.8	—
PRIMARY Part 1, Fe(0-24): Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time 24 for TAK-925 and Its Metabolites M1 and M2	0.028; 0.038; 0.050; 0.110; 0.190; 0.250	—
PRIMARY Part 1, CLR: Renal Clearance of TAK-925 and Its Metabolites M1 and M2	0.01390; 0.01656; 0.02746; 0.05672; 0.1020; 0.1275	—
PRIMARY Part 1, R(CSF/Plasma,ss): Cerebrospinal Fluid/Plasma Drug Concentration at Steady State for TAK-925 and Its Metabolites M1 and M2 in Cohort 4	0.02848; 0.06190; 0.02818	—
SECONDARY Part 2: Average Sleep Latency in Maintenance of Wakefulness Test (MWT)	2.88; 40.00; 37.59; 22.38	<0.0001 sig

Summary

The purpose of this study is to investigate safety, tolerability, and pharmacokinetics of TAK-925 when a single dose of TAK-925 is administered to healthy adult participants, healthy elderly participants and patients with type 1 narcolepsy.

Eligibility Criteria

Inclusion Criteria

Healthy adult participants and Healthy elderly participants:

Participant weighs at least 50 kilogram (kg) (Healthy adults participants) / 40 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 patients:

Patient weighs at least 40 kg inclusive at Screening.
A diagnosis of narcolepsy Type 1, as defined by the International Classification of Sleep Disorders, Third Edition (ICSD-3).
HLA narcolepsy test positivity.
At Day -1, Epworth sleepiness scale (ESS) score greater than or equal to (>=) 10
Blood pressure less than ( ] 400 milligram per day [mg/day]) use one week prior to study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03332784). 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.