A Phase 1 interventional study of TAK-925 and Placebo in Obstructive Sleep Apnea, sponsored by Millennium Pharmaceuticals, Inc.. Completed at 18 sites in United States. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2020-04-20.
Sponsored by Millennium Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Millennium Pharmaceuticals, Inc. is the lead sponsor of 173 studies on the registry; none are open to participants now.
Of its 73 completed or terminated interventional studies of FDA-regulated products, 72 (99%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TAK-925 dose A intravenous (IV) infusion in each treatment sequence (crossover design).
Drug: TAK-925
TAK-925 dose B IV infusion in each treatment sequence (cross over design).
Drug: TAK-925
TAK-925 placebo-matching IV infusion in each treatment sequence (crossover design).
Drug: Placebo
TAK-925 IV infusion
TAK-925 placebo-matching IV infusion
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
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
Plan to share: Yes — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Millennium Pharmaceuticals, Inc.