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

Takeda

Status and phase: Completed; Phase 1

Conditions: Healthy Participants; Narcolepsy

Treatments: Drug: TAK-925; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03748979

JapicCTI-184207 (Registry Identifier)

U1111-1221-3144 (Other Identifier)

TAK-925-1003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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57 participants in 17 patient groups, including a placebo group

Cohort A1; TAK-925 (Dose Level A1)

Experimental group

Description:

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

Treatment:

Drug: TAK-925

Cohort A2; TAK-925 (Dose Level A2)

Experimental group

Description:

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.

Treatment:

Drug: TAK-925

Cohort A3; TAK-925 (Dose Level A3)

Experimental group

Description:

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.

Treatment:

Drug: TAK-925

Cohort A4; TAK-925 (Dose Level A4)

Experimental group

Description:

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.

Treatment:

Drug: TAK-925

Cohort A5; TAK-925 (Dose Level A5)

Experimental group

Description:

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.

Treatment:

Drug: TAK-925

Cohort A6; TAK-925 (Dose Level A6)

Experimental group

Description:

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.

Treatment:

Drug: TAK-925

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

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Cohort B1; TAK-925 (Dose Level B1)

Experimental group

Description:

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

Treatment:

Drug: TAK-925

Cohort B2; TAK-925 (Dose Level B2)

Experimental group

Description:

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.

Treatment:

Drug: TAK-925

Cohort B3; TAK-925 (Dose Level B3)

Experimental group

Description:

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.

Treatment:

Drug: TAK-925

Cohort B4; TAK-925 (Dose Level B4)

Experimental group

Description:

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.

Treatment:

Drug: TAK-925

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

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Cohort C1; TAK-925 (Dose Level C1)

Experimental group

Description:

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.

Treatment:

Drug: TAK-925

Cohort C2; TAK-925 (Dose Level C2)

Experimental group

Description:

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.

Treatment:

Drug: TAK-925

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

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

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

Experimental group

Description:

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

Treatment:

Drug: TAK-925

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

Experimental group

Description:

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.

Treatment:

Drug: TAK-925