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

NCT04091438 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: TAK-925-2002U1111-1238-3314JapicCTI-195087
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 22

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).

Conditions

Idiopathic Hypersomnia

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)

  Study Day 1 up to Study Day 11

• Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests

  Study Day 1 up to Study Day 11

• Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements

  From Predose up to Study Day 4

• Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters

  Study Day 1 up to Study Day 4

Secondary Outcomes (3)

• Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925

  Treatment Periods 1 and 2: Study 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

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925

  Treatment Periods 1 and 2: Study 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

• AUC Last: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-925

  Treatment Periods 1 and 2: Study 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

Study Arms (2)

TAK-925 Dose A + Placebo

EXPERIMENTAL

TAK-925 112 milligram (mg), 9-hour intravenous infusion once on Day 1, Treatment Period 1 followed by 24 hours wash-out period, followed by TAK-925 placebo-matching 9-hour intravenous infusion once on Day 3, Treatment Period 2.

Drug: TAK-925; Drug: TAK-925 Placebo

Placebo + TAK-925 Dose A

PLACEBO COMPARATOR

TAK-925 placebo-matching 9-hour intravenous infusion once on Day 1, Treatment Period 1 followed by 24 hours wash-out period, followed by, TAK-925 112 mg, 9-hour intravenous infusion once on Day 3, Treatment Period 2.

Drug: TAK-925; Drug: TAK-925 Placebo

Interventions

TAK-925 DRUG

TAK-925 IV infusion.

Placebo + TAK-925 Dose A; TAK-925 Dose A + Placebo

TAK-925 Placebo DRUG

TAK-925 placebo-matching IV infusion.

Placebo + TAK-925 Dose A; TAK-925 Dose A + Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Onset of hypersomnia between 10 and 30 years of age.
• 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.
• 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.
• Participants taking medication for treatment of excessive daytime sleepiness (EDS) must be willing to discontinue medication prior to randomization into the study.
• Body mass index (BMI) of 18 through 33 kilogram per square meter (kg/m\^2) inclusive.
• Epworth Sleepiness Scale (ESS) score \>=11 at screening and on Day -2.
• Blood pressure (BP) must be \<140 mmHg (systolic) and \<90 mmHg (diastolic) at screening and Study Day -2.

You may not qualify if:

• 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).
• Positive urine screen for drugs of abuse and/or positive alcohol test at screening and Study Day -2.
• Resting heart rate (HR) outside of the range of 40 to 90 beats pper minute (bpm) off stimulants.
• Screening electrocardiogram (ECG) reveals a QT interval with Fridericia correction method \>450 ms (men) or \>470 ms (women).
• 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.
• 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.
• 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.
• 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).
• 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).
• 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.
• 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.
• 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.
• 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.
• History of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation.
• Known coronary artery disease, a history of myocardial infarction, angina, cardiac rhythm abnormality, or heart failure.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (22)

Wright Clinical Research

Alabaster, Alabama, 35007, United States

Location

Pulmonary Associates Clinical Trials

Glendale, Arizona, 85306, United States

Location

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Stanford School of Medicine

Redwood City, California, 94063, United States

Location

Pacific Research Network, Inc

San Diego, California, 92103, United States

Location

Alpine Clinical Research Center

Boulder, Colorado, 80301, United States

Location

Delta Waves Sleep Disorders and Research Center

Colorado Springs, Colorado, 80918, United States

Location

St Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Pulmonary Disease Specialists, PA, d/b/a PDS Research

Kissimmee, Florida, 34741, United States

Location

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, 32789, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Global Research Associates

Stockbridge, Georgia, 30281, United States

Location

Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders"

Chevy Chase, Maryland, 20815, United States

Location

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, 45212, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

Location

Sleep Therapy & Research Center

San Antonio, Texas, 78229, United States

Location

SOUSEIKAI PS Clinic

Hakata-ku, Fukuoka, 812-0025, Japan

Location

Sumida Hospital

Sumida-ku, Tokyo-To, 130-0004, Japan

Location

Related Publications (1)

• Mignot E, Bogan RK, Emsellem H, Foldvary-Schaefer N, Naylor M, Neuwirth R, Faessel H, Swick T, Olsson T. Safety and pharmacodynamics of a single infusion of danavorexton in adults with idiopathic hypersomnia. Sleep. 2023 Sep 8;46(9):zsad049. doi: 10.1093/sleep/zsad049.

  PMID: 36883238 DERIVED

MeSH Terms

Conditions

Idiopathic Hypersomnia

Interventions

TAK-925

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: January 26, 2020
• Primary Completion: November 19, 2020
• Study Completion: November 23, 2020
• Last Updated: September 26, 2023
• Results First Posted: September 26, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (20); JP (2)