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

NCT ID: NCT03748979

Last Updated: 2020-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-21

Study Completion Date

2019-10-24

Brief Summary

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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

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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

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Healthy Participants Narcolepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort A1; TAK-925 (Dose Level A1)

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

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Cohort A2; TAK-925 (Dose Level A2)

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.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Cohort A3; TAK-925 (Dose Level A3)

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.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Cohort A4; TAK-925 (Dose Level A4)

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.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Cohort A5; TAK-925 (Dose Level A5)

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.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Cohort A6; TAK-925 (Dose Level A6)

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.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Part A (Cohorts A1-A6); TAK-925 Placebo

TAK-925 Placebo, once daily for up to 7 days in healthy participants.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

TAK-925 Placebo

Cohort B1; TAK-925 (Dose Level B1)

TAK-925, Dose Level B1, once daily for up to 7 days in participants with narcolepsy.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Cohort B2; TAK-925 (Dose Level B2)

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.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Cohort B3; TAK-925 (Dose Level B3)

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.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Cohort B4; TAK-925 (Dose Level B4)

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.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Part B (Cohorts B1-B4); TAK-925 Placebo

TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

TAK-925 Placebo

Cohort C1; TAK-925 (Dose Level C1)

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.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Cohort C2; TAK-925 (Dose Level C2)

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.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Part C (Cohorts C1-C2); TAK-925 Placebo

TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

TAK-925 Placebo

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

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

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Cohort A'2; TAK-925 (Dose Level A'2)

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.

Group Type EXPERIMENTAL

TAK-925

Intervention Type DRUG

TAK-925

Interventions

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TAK-925

TAK-925

Intervention Type DRUG

Placebo

TAK-925 Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Sumida Hospital

Sumida-ku, Tokyo, Japan

Site Status

Hakata Clinic

Fukuoka, , Japan

Site Status

PS Clinic

Fukuoka, , Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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U1111-1221-3144

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-184207

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-925-1003

Identifier Type: -

Identifier Source: org_study_id