Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Lik… (NCT01892189) | Clinical Trial Compass
CompletedPhase 1
Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults
United States27 participantsStarted 2013-08
Plain-language summary
The purpose of this study is to determine whether ketamine-induced brain activity changes are modulated by TAK-063 administration using neuroimaging battery tests.
Who can participate
Age range18 Years – 45 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. In the opinion of the investigator, participant is capable of understanding and complying with protocol requirements.
✓. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
✓. Is a healthy adult male.
✓. Speaks English as their first language.
✓. Is aged 18 to 45 years, inclusive, at the time of informed consent and first dose of study drug.
✓. Weighs at least 50 kg and has a body mass index (BMI) between 18 and 32 kilogram per metre square (kg/m\^2), inclusive at Screening.
✓. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
✓. Has a normal magnetic resonance imaging (MRI) scan and electroencephalogram (EEG) measurement at Screening.
Exclusion criteria
✕. Has received any investigational compound or ketamine within 30 days prior to Day 1 of Period 1.
✕. Has received TAK-063 in a previous clinical study or as a therapeutic agent.
✕. Is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
What they're measuring
1
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Timeframe: Day 1: 4 hours post TAK-063 dose or placebo
✕. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality (including MRI or EEG), which may impact the ability of the participant to participate or potentially confound the study results.
✕. Has a known hypersensitivity to any component of the formulation of TAK-063 or ketamine.
✕. Has a contraindication for ketamine.
✕. Has a positive result for drugs or alcohol at Screening or Check-in (Day -1 of Period 1).
✕. Has a history of drug or alcohol abuse or dependence (as defined by Diagnostic \& Statistical Manual of Mental Disorders, fourth Edition \[DSM-IV\]) within 1 year prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.