CompletedPhase 1

An [^11C]T-773 Positron Emission Tomography (PET) Study to Determine Phosphodiesterase10A Occupancy by TAK-063

13 participantsStarted 2013-10

Plain-language summary

The purpose of this study is to estimate phosphodiesterase 10A (PDE10A) occupancy in brain following a single dose of TAK-063.

Age range20 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Has never previously participated in a positron emission tomography (PET) study (lifetime).
✓. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
✓. The participant, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
✓. Is a healthy adult male, as determined by a physician based upon medical history and physical examination findings at Screening.
✓. Is aged 20 to 45 years, inclusive, at the time of informed consent.
✓. Weighs at least 50 kg and less than 100 kg and has a body mass index (BMI) between 18 and 32 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 clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) within the reference range for the testing laboratory, unless the results are deemed not to be clinically significant (CS) by the investigator or sponsor at screening. Participants must have normal hemoglobin levels.

✕. Has received any investigational compound within 90 days prior to Screening.
✕. 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 dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
✕. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, 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 \[\^11C\]T-773.
✕. Has a positive urine drug result for drugs of abuse or a positive breathalyzer test for alcohol at Screening or Day -1.
✕. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the screening visit or is unwilling to agree to abstain from alcohol until discharge from the Phase 1 unit and drugs throughout the study.
✕. Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.

Phosphodiesterase 10A (PDE10A) Occupancy of Brain Regions With [^11C]T-773 at 3 Hours Following a Single Dose of TAK-063

Timeframe: 3 hours post-dose

NCT IDNCT02370602

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02

Results submitted2015-03-11

Who can participate

Age range20 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Has never previously participated in a positron emission tomography (PET) study (lifetime).
✓. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
✓. The participant, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
✓. Is a healthy adult male, as determined by a physician based upon medical history and physical examination findings at Screening.
✓. Is aged 20 to 45 years, inclusive, at the time of informed consent.
✓. Weighs at least 50 kg and less than 100 kg and has a body mass index (BMI) between 18 and 32 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 clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) within the reference range for the testing laboratory, unless the results are deemed not to be clinically significant (CS) by the investigator or sponsor at screening. Participants must have normal hemoglobin levels.

✕. Has received any investigational compound within 90 days prior to Screening.
✕. 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 dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
✕. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, 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 \[\^11C\]T-773.
✕. Has a positive urine drug result for drugs of abuse or a positive breathalyzer test for alcohol at Screening or Day -1.
✕. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the screening visit or is unwilling to agree to abstain from alcohol until discharge from the Phase 1 unit and drugs throughout the study.
✕. Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.