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A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia

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ClinicalTrials.gov Identifier: NCT04091438
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adult participants with idiopathic hypersomnia (IH).

Condition or disease Intervention/treatment Phase
Idiopathic Hypersomnia Drug: TAK-925 Drug: TAK-925 Placebo Phase 1

Detailed Description:

The drug being tested in this study in participants with IH is called TAK-925. The study will have 2-treatment crossover groups. The study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single intravenous (IV) dose of Dose A in participants with IH.

The study will enroll 40 patients. Participants will be randomly assigned to one of the two treatment sequence groups as indicated below:

  • TAK-925 + Placebo
  • Placebo + TAK-925

On Day 1 of each treatment period, TAK-925 or placebo will be administered as a single 9-hour IV infusion.

The multicenter study will be conducted in the United States and Japan. The overall duration of treatment in this study is approximately 41 days including screening up to 28 days, confinement for 6 days and end of study follow up telephone call on Study Day 11.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Crossover Study of a Single Intravenous Infusion Dose of TAK-925 in Patients With Idiopathic Hypersomnia
Actual Study Start Date : January 26, 2020
Estimated Primary Completion Date : July 17, 2021
Estimated Study Completion Date : July 17, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAK-925 Dose A + Placebo
TAK-925 Dose A, 9-hour IV infusion once on Day 1, Treatment Period 1 followed by 24 hours wash-out period, followed by TAK-925 placebo-matching 9-hour IV infusion once on Day 3, Treatment Period 2.
Drug: TAK-925
TAK-925 IV infusion.

Drug: TAK-925 Placebo
TAK-925 placebo-matching IV infusion.

Placebo Comparator: Placebo + TAK-925 Dose A
TAK-925 placebo-matching 9-hour IV infusion once on Day 1, Treatment Period 1 followed by 24 hours wash-out period, followed by, TAK-925 Dose A, 9-hour IV infusion once on Day 3, Treatment Period 2.
Drug: TAK-925
TAK-925 IV infusion.

Drug: TAK-925 Placebo
TAK-925 placebo-matching IV infusion.




Primary Outcome Measures :
  1. Percentage of Participants who Experience at Least One Treatment Emergent Adverse Event (TEAE) [ Time Frame: Baseline up to 7 days after the last dose of study drug (Up to Day 11) ]
    An Adverse Event (AE) is 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 is defined as an AE with an onset that occurs after receiving study drug.

  2. Percentage of Participants who Meet the Markedly Abnormal Criteria for Clinical Safety Laboratory Tests at Least Once Post a Regimen [ Time Frame: Baseline up to Day 4 ]
    Clinical laboratory evaluations include hematology, blood chemistry, and urinalysis.

  3. Percentage of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post a Regimen [ Time Frame: Baseline up to Day 4 ]
    Vital signs include body temperature, respiratory rate, systolic and diastolic blood pressure and heart rate.

  4. Percentage of Participants who Meet the Markedly Abnormal Criteria for 12-Lead Safety Electrocardiogram (ECG) Parameters at Least Once Post a Regimen [ Time Frame: Baseline up to Day 4 ]
    A standard 12-lead ECG will be performed.


Secondary Outcome Measures :
  1. Ceoi: Observed Plasma Concentration at the end of Infusion for TAK-925 [ Time Frame: Periods 1 and 2: Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion ]
  2. AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-925 [ Time Frame: Periods 1 and 2: Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion ]
  3. AUC last: Area Under the Plasma Concentration-Time Curve from Time 0 to Time of the Last Quantifiable Concentration for TAK-925 [ Time Frame: Periods 1 and 2: Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion ]


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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A diagnosis of IH, as defined by the International Classification of Sleep Disorders-3 (ICSD-3) as verified by a previous nocturnal polysomnography (nPSG) and multiple sleep latency test (MSLT) study performed within the last 10 years.
  2. Onset of hypersomnia between 10 and 30 years of age.
  3. Seven consecutive days of actigraphy supported by a sleep diary obtained prior to the nPSG (Study Day -2) shows an average nightly sleep duration of greater than or equal to (>=) 420 minutes during the participant's normal nocturnal sleep period.
  4. nPSG (Study Day -2) demonstrates that participant does not have other comorbid sleep disorders or clinically significant nocturnal hypoxemia (oxygen saturation ≤80% for ≥5% of total sleep time) and that their Apnea-Hypopnea Index (AHI) is less than or equal to (<=) 10 per hour, their periodic limb movement arousal index (PLMAI) <=15/hour, and that their total sleep time is >=6.5 hours.
  5. Participants taking medication for treatment of excessive daytime sleepiness (EDS) must be willing to discontinue medication prior to randomization into the study.
  6. Body mass index (BMI) of 18 through 33 kilogram per square meter (kg/m^2) inclusive.
  7. Epworth Sleepiness Scale (ESS) score >=11 at screening and on Day -2.
  8. Blood pressure (BP) must be <140 mmHg (systolic) and <90 mmHg (diastolic) at screening and Study Day -2.

Exclusion Criteria:

  1. Average nightly sleep duration is <=8 hours (480 minutes) and has insufficient sleep syndrome as evidenced by sleeping >2 hours/night more on "off-days" relative to "work days" as determined by actigraphy and sleep diary obtained prior to the nPSG (Study Day -2).
  2. Positive urine screen for drugs of abuse and/or positive alcohol test at screening and Study Day -2.
  3. Resting heart rate (HR) outside of the range of 40 to 90 beats pper minute (bpm) off stimulants.
  4. Screening electrocardiogram (ECG) reveals a QT interval with Fridericia correction method >450 ms (men) or >470 ms (women).
  5. Usual bedtime later than 24:00 (midnight) or an occupation requiring nighttime shift work or variable shift work within the past 6 months, or travel with significant jet lag within 14 days before Study Day -2.
  6. History of a sleep disorder other than IH, based on interviews at the screening visit, such as obstructive sleep apnea (OSA), restless legs syndrome, or periodic limb movements of sleep (PLMS) associated with arousals.
  7. Use of any over-the-counter (OTC) or prescription medications with stimulating properties within 7 days prior to dosing or 5 half-lives (whichever is longer) that could affect the evaluation of EDS or use of sodium oxybate within 3 months of screening.
  8. Nicotine dependence that is likely to have an effect on sleep (e.g., a participant who routinely awakens at night to smoke) and/or an unwillingness to discontinue all smoking and nicotine use during the confinement portion of the study (Day -2 to Day 4).
  9. Caffeine consumption of more than 600 mg/day for 7 days before Study Day 1 (1 serving of coffee is approximately equivalent to 120 mg of caffeine) and/or unwilling to discontinue all caffeine during the confinement portion of the study (Day -2 to Day 4).
  10. Alcohol use that is likely to have an effect on sleep and/or an unwillingness to discontinue all alcohol use from 72 hours before check-in through discharge on Study Day 4.
  11. History of epilepsy or seizures, including having had a single seizure or a history of childhood febrile seizures or has a clinically significant history of head trauma.
  12. Answered "YES" on Questions 4 or 5 on the Suicidal Ideation subscale of the Columbia Suicide Severity Rating Scale (C-SSRS) at screening (defined period as 3 months prior to screening) or evidence of suicidal behavior within 6 months of screening as measured by the Suicidal Behavior subscale of the C-SSRS.
  13. Diagnosis of major depressive disorder (DSM-5), within the past 6 months or Beck Depression Inventory II (BDI-II) total score of >16 at the screening visit.
  14. History of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation.
  15. Known coronary artery disease, a history of myocardial infarction, angina, cardiac rhythm abnormality, or heart failure.

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): NCT04091438


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medinfoUS@takeda.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Director Clinical Science Takeda
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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04091438    
Other Study ID Numbers: TAK-925-2002
U1111-1238-3314 ( Registry Identifier: WHO )
JapicCTI-195087 ( Registry Identifier: JapicCTI )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
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: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Drug therapy
Additional relevant MeSH terms:
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Disorders of Excessive Somnolence
Hypersomnolence, Idiopathic
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders