Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Participan… (NCT01879722) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Participants With Stable Schizophrenia and Healthy Participants
United States77 participantsStarted 2013-06
Plain-language summary
The purpose of this study is to characterize the safety and tolerability of TAK-063 when administered as multiple oral doses at escalating dose levels in participants with stable schizophrenia and in healthy Japanese participants.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 20-55 years, inclusive, at the time of informed consent and first study medication dose.
✓. Is a healthy adult male or female of Japanese descent (born to Japanese parents and grandparents and has lived outside of Japan for less than 5 years).
✓. Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 28.0 kg/m\^2, inclusive, at Screening.
✓. Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
✓. Is an adult male or female with a diagnosis of schizophrenia or schizoaffective disorder.
✓. Weighs at least 45 kg and has a BMI between 18.0 and 35.0 kg/m\^2, inclusive at Screening.
✓. Has been receiving a stable dose of antipsychotic monotherapy for at least 1 month prior to Screening.
✓. Has not had an acute exacerbation of psychosis or been hospitalization for the treatment of schizophrenia or schizoaffective disorder for at least 3 months prior to Screening.
Exclusion criteria
✕. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.
✕. If female, the participant is pregnant or lactating or intending to become pregnant, or intending to donate ova, before, during the course of the study or within 12 weeks after last dose.
What they're measuring
1
Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing
Timeframe: Day 1 to Day 14
2
Percentage of Participants With Markedly Abnormal Safety Laboratory Tests
Timeframe: Day 1 to Day 8
3
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Timeframe: Day 1 to Day 8
4
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters
✕. Intends to donate sperm during the course of this study or for 12 weeks after last dose.
✕. Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-063, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
✕. Has a history or treatment of Axis I/II mental disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) such as depression, anxiety disorders, bipolar disorder, attention deficit hyperactivity disorder (ADHD), autism spectrum disorders, anorexia nervosa, bulimia nervosa or schizophrenia within the past 3 years.
✕. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1. Cotinine test is positive at Screening or Check-in (Day -1).
✕. Has a history of a primary DSM-IV axis I diagnosis other than schizophrenia or schizoaffective disorder.
✕. Has not discontinued antipsychotic or other psychotropic medications or is unable to discontinue antipsychotic or other psychotropic medications at Day -7 (or five half-lives prior to Day -1).