A TAK-831-1001, Single and Multiple Rising Dose Study in Healthy Participants (NCT02566759) | Clinical Trial Compass
TerminatedPhase 1
A TAK-831-1001, Single and Multiple Rising Dose Study in Healthy Participants
Stopped: The study was terminated by Takeda due to the discomfort observed in the study participants from the CSF collection procedure in Part 3 of the study.
United Kingdom110 participantsStarted 2015-09-23
Plain-language summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics (PK) of single and multiple rising doses of TAK-831 in healthy participants.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Should be 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.
✓. Healthy male or female aged between 18 to 55 years- Weighing 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).
✓. 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.
✓. Female participant with no childbearing potential, defined as a participant that has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who is post menopausal (defined as continuous amenorrhea of at least 2 years and follicle-stimulating hormone \[FSH\] greater than \[\>\] 40 international units per liter \[IU/L\]).
Exclusion criteria
✕. Received any investigational compound within 3 months prior to randomization.
✕. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
✕. Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
What they're measuring
1
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Timeframe: Baseline up to 30 days after the last dose of study drug (Part 1 Day 31, Part 2 Day 46, Part 3 Day 44 and Part 4 Day 43)
2
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Timeframe: Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
3
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Timeframe: Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
4
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Timeframe: Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4
✕. Has a known hypersensitivity to any component of the formulation of TAK-831.
✕. Female participant is of childbearing potential.
✕. Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in.
✕. 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 and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 single measure of spirits or 1 small glass of wine.
✕. Has taken any excluded medication, supplements, or food products during the time periods listed in the excluded medications and dietary products.