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

NCT03748979 | Completed Phase 1 Results

• 3 other identifiers: TAK-925-1003U1111-1221-3144JapicCTI-184207
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Healthy Participants; Narcolepsy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  Baseline, Day 1 and Day 7

Study Arms (17)

Cohort A1; TAK-925 (Dose Level A1)

EXPERIMENTAL

TAK-925, Dose Level A, once daily for up to 7 days in healthy participants.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Drug: Placebo

Cohort A'1; TAK-925 (Dose Level A'1)

EXPERIMENTAL

TAK-925, Dose Level A'1, single dose in healthy participants.

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.

Drug: TAK-925

Interventions

TAK-925 DRUG

TAK-925

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)

Placebo DRUG

TAK-925 Placebo

Part A (Cohorts A1-A6); TAK-925 Placebo; Part B (Cohorts B1-B4); TAK-925 Placebo; Part C (Cohorts C1-C2); TAK-925 Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (3)

Sumida Hospital

Sumida-ku, Tokyo, Japan

Location

Hakata Clinic

Fukuoka, Japan

Location

PS Clinic

Fukuoka, Japan

Location

MeSH Terms

Conditions

Narcolepsy

Interventions

TAK-925

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Medical director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 21, 2018
• Study Start: November 21, 2018
• Primary Completion: October 24, 2019
• Study Completion: October 24, 2019
• Last Updated: December 8, 2020
• Results First Posted: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (3)