A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935

Completed · Phase 1

Conditions studied: Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents

In brief

The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H) enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron emission tomography (PET) ligand \[18F\]MNI-792 and PET imaging and to determine the relationship of occupancy to TAK-935 exposure.

Key facts

Study ID

NCT02497235

Run by

Takeda

People needed

11

Starts

2015-07-01

Expected to finish

2016-01-01

Last updated by the study team

2017-04-11

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• In the opinion of the investigator, is capable of understanding and complying with protocol requirements.
• Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
• Is a healthy male or female and aged 19 to 55 years, inclusive, at the time of informed consent and first study medication dose.
• Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m\^2), inclusive at Screening.
• A female of non-bearing potential (example post-menopausal by history; or history of hysterectomy, bilateral salpingectomy, or oophorectomy).

You may not qualify if…

• Have 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 safety or interfere with the study evaluation, procedures or completion.
• Contraindication to magnetic resonance imaging (MRI) based on the standard MRI radiography screening questionnaire.
• Had exposure to any radiation greater than (>) 15 millisievert (mSv)/year (example, occupational or radiation therapy) within the previous year prior to Baseline imaging.
• Has a known hypersensitivity to any component of the formulation of TAK-935 or related compounds, or to [18F]MNI-792 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 PET imaging.
• Use of any over-the-counter, herbal, or prescription medications or supplements within 30 days prior to baseline imaging.

Where it is running

• Study site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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