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A Pharmacokinetic and Safety Study of TAK-925 in Participants With Idiopathic Hypersomnia

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ClinicalTrials.gov Identifier: NCT04091438
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
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 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 is called TAK-925. TAK-925 is being tested to treat participants who have IH. 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.

  • 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 infusion.

The multicentre study will be conducted in US and Japan. The overall duration of treatment in this study is approximately 39 days. Participants make multiple visits to the clinic and will be followed up 7 days after the end of treatment for safety follow-up.


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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 TAK-925 in Patients With Idiopathic Hypersomnia
Estimated Study Start Date : February 12, 2020
Estimated Primary Completion Date : July 3, 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 30 days after the last dose of study drug (Up to Day 34) ]
    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 7 days after the last dose of study drug (Up to Day 11) ]
    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 7 days after the last dose of study drug (Up to Day 11) ]
    Vital signs includes body temperature, 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 30 days after the last dose of study drug (Up to Day 34) ]
    A standard 12-lead ECG will be performed.


Secondary Outcome Measures :
  1. Ceoi: Observed Plasma Concentration at the end of Infusion [ Time Frame: 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 [ Time Frame: 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. AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to Time of the Last Quantifiable Concentration [ Time Frame: 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 ]


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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 medical records.
  2. Onset of hypersomnia between 10 and 30 years of age.
  3. Nocturnal polysomnography (NPSG) 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 ≤10.
  4. Participants taking medication for treatment of excessive daytime sleepiness (EDS) must be willing to discontinue medication prior to randomization into the study.
  5. Body mass index (BMI) of 18 to 38.5 kg/m^2 inclusive.
  6. Epworth Sleepiness Scale (ESS) score ≥11 at screening
  7. The participant must be normotensive, with no history of hypertension or use of antihypertensive medication. Blood pressure (BP) must be <140 mmHg (systolic) and <90 mmHg (diastolic).

Exclusion Criteria:

  1. Actigraphy obtained the week prior to NPSG at Study Day -2 Visit shows an average sleep duration of <420 minutes.
  2. Participants on 300 mg of venlafaxine per day.
  3. 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.
  4. Nicotine dependence that is likely to have an effect on sleep (eg, a participant who routinely awakens at night to smoke) and/or unwilling to discontinue all smoking and nicotine use during the study.
  5. Recent history of a major depressive disorder (DSM-5), Beck depression inventory >16 and/or item G >0 at the screening visit.

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 medicalinformation@tpna.com

Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Director Takeda

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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04091438     History of Changes
Other Study ID Numbers: TAK-925-2002
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 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: 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