A Study With [18F]MNI-1054 to Determine Lysine -Specific Demethylase 1A (LSD1) Brain Enzyme Occupancy of TAK-418 After Single-Dose Oral Administration in Healthy Participants

Stopped early · Phase 1

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to determine brain LSD1 enzyme occupancy and the relationship of occupancy to TAK-418 dose and plasma exposure after single oral dosing of TAK-418 in healthy participants using \[18F\]MNI-1054 positron emission tomography (PET) imaging.

Key facts

Study ID

NCT04202497

Run by

Takeda

People needed

7

Starts

2019-12-18

Expected to finish

2020-03-19

Last updated by the study team

2021-07-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The participant 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.
• The participant must be a current nonsmoker at screening as demonstrated by negative cotinine test.
• The participant has adequate circulation to both hands for safe placement of arterial lines (as determined by Allen's test).

You may not qualify if…

• Has a known hypersensitivity to any component of the formulation of TAK-418 or related compounds, including [18F]MNI-1054.
• The participant has a positive alcohol or drug screen.
• The participant has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer [354 milliliter (mL)/12 ounce (oz)], wine [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day).
• The participant 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.
• The participant has a substance abuse disorder.
• The participant cannot tolerate venipuncture or has poor venous access that would cause difficulty in collecting blood samples.
• The participant has contraindications to undergoing magnetic resonance imaging (MRI) examination including but not limited to implants, such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, central nervous system aneurysm clips, and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
• The participant has clinically significant abnormal findings on brain MRI scan that in the opinion of the investigator may interfere with the interpretation of the PET imaging.
• The participant has experienced an acute illness within 10 days before the screening visit.
• The participant has a risk of suicide according to the investigator's clinical judgement per the Columbia-Suicide Severity Rating Scale at screening or has made a suicide attempt in the 12 months before screening.
• The participant has luteinizing hormone, follicle stimulating hormone (FSH), or estradiol levels that are clinically abnormal.
• The participant has existing skin rashes that can be diagnosed as dermatitis.

Where it is running

• Invicro, A Konica Minolta Company — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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