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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748979
Recruitment Status : Completed
First Posted : November 21, 2018
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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 patients.

Condition or disease Intervention/treatment Phase
Healthy Participants Narcolepsy Drug: TAK-925 Drug: Placebo Phase 1

Detailed Description:

The drug being tested in this study is called TAK-925. TAK-925 is being tested in healthy participants and patients 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 patients with narcolepsy. Part C is a randomized, double-blind, placebo-controlled, parallel group, multiple repeat dose study in patients 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 patient 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 3-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Patients With Narcolepsy
Actual Study Start Date : November 21, 2018
Actual Primary Completion Date : October 25, 2019
Actual Study Completion Date : October 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A1; TAK-925 (Dose Level A1)
TAK-925, Dose Level A, once daily for up to 7 days in healthy participants.
Drug: TAK-925
TAK-925

Experimental: 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.
Drug: TAK-925
TAK-925

Experimental: 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.
Drug: TAK-925
TAK-925

Experimental: 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.
Drug: TAK-925
TAK-925

Experimental: 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.
Drug: TAK-925
TAK-925

Experimental: 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.
Drug: TAK-925
TAK-925

Placebo Comparator: Part A (Cohorts A1-A6); TAK-925 Placebo
TAK-925 Placebo, once daily for up to 7 days in healthy participants.
Drug: Placebo
TAK-925 Placebo

Experimental: Cohort B1; TAK-925 (Dose Level B1)
TAK-925, Dose Level B1, once daily for up to 7 days in patients with narcolepsy.
Drug: TAK-925
TAK-925

Experimental: Cohort B2; TAK-925 (Dose Level B2)
TAK-925, Dose Level B2, once daily for up to 7 days in patients with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
Drug: TAK-925
TAK-925

Experimental: Cohort B3; TAK-925 (Dose Level B3)
TAK-925, Dose Level B3, once daily for up to 7 days in patients 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
TAK-925

Experimental: Cohort B4; TAK-925 (Dose Level B4)
TAK-925, Dose Level B4, once daily for up to 7 days in patients 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
TAK-925

Placebo Comparator: Part B (Cohorts B1-B4); TAK-925 Placebo
TAK-925 Placebo, once daily for up to 7 days in patients with narcolepsy.
Drug: Placebo
TAK-925 Placebo

Experimental: Cohort C1; TAK-925 (Dose Level C1)
TAK-925, Dose Level C1, once daily for up to 7 days in patients with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts.
Drug: TAK-925
TAK-925

Experimental: Cohort C2; TAK-925 (Dose Level C2)
TAK-925, Dose Level C2, once daily for up to 7 days in patients 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
TAK-925

Placebo Comparator: Part C (Cohorts C1-C2); TAK-925 Placebo
TAK-925 Placebo, once daily for up to 7 days in patients with narcolepsy.
Drug: Placebo
TAK-925 Placebo

Experimental: Cohort A'1; TAK-925 (Dose Level A'1)
TAK-925, Dose Level A'1, single dose in healthy participants.
Drug: TAK-925
TAK-925

Experimental: 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.
Drug: TAK-925
TAK-925




Primary Outcome Measures :
  1. Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Up to Day 15 ]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.


Secondary Outcome Measures :
  1. Observed Plasma Concentration at the End of Administration for TAK-925 in Parts A, B and C [ Time Frame: Up to Day 8 ]
  2. Area Under the Plasma Concentration-Time Curve during a Dosing Interval (AUCtau) for TAK-925 in Parts A, B and C [ Time Frame: Up to Day 8 ]
  3. Accumulation Ratio Based on AUCtau for TAK-925 in Parts A, B and C [ Time Frame: Up to Day 8 ]
  4. Change from Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) to Days 1 and 7 in Parts B and C [ Time Frame: Baseline to Day 1 and to Day 7 ]
    The reported data for this outcome measure will be percentage of the participant who recorded the MWT over 40 minutes in Day 1 and Day 7 in Parts B and C. The MWT is a measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. In the MWT, time from start of the test to the time point of falling asleep will be measured.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy adult participants and Healthy elderly participants:

• Participant weighs at least 50 kg (Healthy adults participants) / 40 kg (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kg/m^2, inclusive at Screening.

Narcolepsy patients:

  • Patient 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748979


Locations
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Japan
Sumida Hospital
Sumida-ku, Tokyo, Japan
Hakata Clinic
Fukuoka, Japan
PS Clinic
Fukuoka, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03748979    
Other Study ID Numbers: TAK-925-1003
U1111-1221-3144 ( Other Identifier: WHO )
JapicCTI-184207 ( Registry Identifier: JapicCTI )
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders