Status:
COMPLETED
A Study to Evaluate Central Nervous System (CNS) Pharmacodynamic Activity of TAK-653 in Healthy Participants Using Transcranial Magnetic Stimulation (TMS)
Lead Sponsor:
Neurocrine Biosciences
Collaborating Sponsors:
Takeda
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to determine whether TAK-653, in comparison to placebo, increases CNS excitability, assessed with TMS-evoked motor-evoked potential (MEP) in healthy participants.
Detailed Description
The drug being tested in this study is called TAK-653. This study is designed to evaluate the central pharmacodynamic activity of TAK-653 using TMS. The study will enroll approximately 24 participants...
Eligibility Criteria
Inclusion
- Must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead electrocardiogram (ECG), and vital sign measurements performed at the screening visit and before the first dose of study drug.
- Must be male or female (of nonchildbearing potential) aged 18 to 55 years, inclusive, at the screening visit.
- Must have a body mass index (BMI) greater than or equal to (\>=) 18.5 and less than or equal to (\<=) 30.0 kilogram per square meter (kg/m\^2) at the screening visit.
Exclusion
- Has a positive alcohol or drug screen.
- Had major surgery or donated or lost 1 unit of blood (approximately 500 milliliter \[mL\]) within 4 weeks before the screening visit.
- Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer \[354 mL/12 ounce (oz)\], wine \[118 mL/4 oz\], or distilled spirits \[29.5 mL/1 oz\] per day).
- Who regularly smoke more than 5 cigarettes daily or equivalent and unable or unwilling not to smoke during the in-house period.
- Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
- Has a previous or current clinically significant psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) including substance use disorder.
- Has a history of intracranial mass lesion, hydrocephalus and/or head injury or trauma.
- Has metal objects in brain or skull.
- Has a cochlear implant or deep brain stimulation device.
- Has a history of epilepsy, seizures, or convulsions.
- Has a family history of epilepsy, seizures, or convulsions.
- Has abnormal sleeping patterns (example, working night shifts)
- Has an rMT of more than 75% of the maximum stimulator output, measured using TMS-electromyogram (EMG) during screening.
Key Trial Info
Start Date :
February 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03792672
Start Date
February 11 2019
End Date
June 18 2019
Last Update
March 19 2021
Active Locations (1)
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1
CHDR
Leiden, Netherlands