Phase 1 TAK-915 Single-Dose Positron Emission Tomography (PET) Occupancy Study
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
This phase 1 study will be conducted to examine the degree and duration of brain PDE2A enzyme occupancy /target engagement as a function of TAK-915 plasma concentration in order to guide dosing and schedule for future clinical studies in schizophrenia with TAK-915.
Key facts
- Study ID
- NCT02584569
- Run by
- Takeda
- People needed
- 12
- Starts
- 2015-11-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2016-07-21
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Is a healthy male, or female of non-childbearing potential, aged between 18 and 55 years, inclusive.
- Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m\^2.
You may not qualify if…
- Has a known history or evidence of a clinically significant disorder (including neurologic and psychiatric) or disease that in the opinion of the study investigator would pose a risk to the participant's safety or interfere with the study evaluation, procedures, or completion.
- Contraindication to magnetic resonance imaging (MRI) based on the standard MRI screening questionnaire.
- Have had exposure to any radiation >15 millisievert (mSv)/year (eg, occupational or radiation therapy) within the previous year prior to Baseline imaging.
- Has a known hypersensitivity to any component of the formulation of TAK-915 or related compounds, or to [18F]MNI-794 or to any of its components.
- Clinically significant abnormal findings on brain MRI scan or findings on brain MRI that may interfere with the interpretation of the positron emission tomography (PET) imaging.
- Use of any herbal or prescription medications within 30 days prior to Baseline Imaging Check-in; use of any over-the-counter medications or vitamin supplements within 7 days prior to Baseline Imaging Check-in.
Where it is running
- Study site — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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