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 range

18 Years – 55 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since TAK-063 was tested in a Phase 1 trial focused mainly on safety and tolerability over just 7 days of dosing, what does that short timeframe tell us about whether its long-term safety for treating schizophrenia is actually established yet?
2The trial specifically tracked heart rhythm changes through ECG measurements — is there anything in the results of this study that would be a concern for my particular heart health or any medications I'm already taking?
3This study included both people with stable schizophrenia and healthy volunteers, so where does that leave someone in my situation — would my current symptom level or treatment history affect whether anything learned in this trial is relevant to me?
4Because this was a Phase 1 dose-ranging study, it wasn't designed to test whether TAK-063 actually improves schizophrenia symptoms — should I be looking at later-phase trials of this drug, or would sticking with or adjusting my current treatment be a more proven path right now?
5The trial measured things like abnormal lab tests and vital sign changes — do you know if any particular dose levels raised concerns in those areas, and how would that factor into whether TAK-063 is worth pursuing further for someone like me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing

Timeframe: Day 1 to Day 14

Percentage of Participants With Markedly Abnormal Safety Laboratory Tests

Timeframe: Day 1 to Day 8

Percentage of Participants With Markedly Abnormal Vital Sign Measurements

Timeframe: Day 1 to Day 8

Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters

Timeframe: Day 1 to Day 8

Trial details

NCT IDNCT01879722

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-06

Results submitted2015-06-25

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

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.

What they're measuring

Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing

Timeframe: Day 1 to Day 14

Percentage of Participants With Markedly Abnormal Safety Laboratory Tests

Timeframe: Day 1 to Day 8

Percentage of Participants With Markedly Abnormal Vital Sign Measurements

Timeframe: Day 1 to Day 8

Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters

Timeframe: Day 1 to Day 8