The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adults with obstructive sleep apnea (OSA) who are experiencing excessive daytime sleepiness (EDS) despite adequate use of CPAP as the primary OSA therapy.
The drug being tested in this study is called TAK-925. TAK-925 is being tested to treat participants who have EDS due to OSA despite using CPAP. The study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single IV dose of TAK-925 in participants with OSA. The study will enroll approximately 42 patients. The study will utilize a three-way cross over design with a 24 hour wash-out between each treatment. On Day 1 of each treatment period, TAK-925 or placebo will be administered as a single 9-hour IV infusion. The multi-center study will be conducted in United States. The patient's participation in the study will last for up to 43 days and include an 8-day stay in the study clinic and a safety follow-up phone call 7 days after the end of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Wright Clinical Research
Alabaster, Alabama, United States
Pulmonary Associates Clinical Trials
Percentage of Participants who Experience at Least One Treatment Emergent Adverse Event (TEAE)
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.
Time frame: Up to approximately 43 days
Percentage of Participants who Meet the Markedly Abnormal Criteria for Clinical Safety Laboratory Tests at Least Once Post a Regimen
Clinical laboratory evaluations include hematology, blood chemistry, and urinalysis.
Time frame: Up to approximately 43 days
Percentage of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post a Regimen
Vital signs include heart rate, respiratory rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Time frame: Up to approximately 43 days
Percentage of Participants who Meet the Markedly Abnormal Criteria for 12-Lead Safety Electrocardiogram (ECG) Parameters at Least Once Post a Regimen
A standard 12-lead ECG will be performed.
Time frame: Up to approximately 43 days
Ceoi: Observed Plasma Concentration at the end of Infusion for TAK-925
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 on Day 1 each Treatment Period
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Glendale, Arizona, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Stanford School of Medicine
Redwood City, California, United States
Pacific Research Network, Inc
San Diego, California, United States
Delta Waves Sleep Disorders and Research Center
Colorado Springs, Colorado, United States
MD Clinical
Hallandale, Florida, United States
Research Centers of America
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Pulmonary Disease Specialists, PA, d/b/a PDS Research
Kissimmee, Florida, United States
...and 8 more locations
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-925
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 on Day 1 each Treatment Period
AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to Time of the Last Quantifiable Concentration for TAK-925
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 on Day 1 of each Treatment Period