CompletedPhase 1

Safety and PK Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Stable Schizophrenia

United States60 participantsStarted 2015-02

Plain-language summary

This is an open-label, multiple dose, PK and safety study in patients with chronic, stable schizophrenia or schizoaffective disorder.

Age range18 Years – 60 Years

SexALL

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

✓. Male or female patients 18 - 60 years of age, inclusive.
✓. Diagnosis of schizophrenia, or schizoaffective disorder as per DSM-V criteria in the past 6 months or more, dependent on diagnosis.
✓. Currently on maintenance antipsychotic medication (ie, patients treated with antipsychotic medication with stable doses in the 4 weeks prior to Screening and no psychosis-related dose changes in the 8 weeks prior to Screening).
✓. Body Mass Index (BMI) ≥20 and ≤40 kg/m2.
✓. Female patients who are non-childbearing potential (surgically sterile \[hysterectomy\]) or post-menopausal ≥2 years; or non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide, or intrauterine device) from Screening until the End-of-Study visit.
✓. No clinically significant abnormal laboratory values.
✓. No clinically significant findings in the 12-lead ECG.
✓. No clinically significant findings from a vital signs measurement.

✕. Unwilling to provide genotyping (phenotyping) sample for CYP2D6.
✕. Have known or suspected carcinoma.
✕. Have known presence or history of renal or hepatic insufficiency.
✕. Have known history, hypersensitivity or clinically significant idiosyncratic reaction to risperidone, paliperidone, and/or any other drug substance with similar activity.
✕. Have a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period immediately prior to Screening.
✕. Have a history of epilepsy or risk of having seizures.
✕. Are pregnant, lactating, or likely to become pregnant during the study.
✕. Have taken an antipsychotic depot product (including investigational products) within the 60 days prior to Screening.

PK profile of ZX003 determined by C max, T max, C min, AUC (0-24h), AUC (0-tau), C avg

Timeframe: Day 1 through day 120

NCT IDNCT02411526

SponsorZogenix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-09

Who can participate

Age range18 Years – 60 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.

✓. Male or female patients 18 - 60 years of age, inclusive.
✓. Diagnosis of schizophrenia, or schizoaffective disorder as per DSM-V criteria in the past 6 months or more, dependent on diagnosis.
✓. Currently on maintenance antipsychotic medication (ie, patients treated with antipsychotic medication with stable doses in the 4 weeks prior to Screening and no psychosis-related dose changes in the 8 weeks prior to Screening).
✓. Body Mass Index (BMI) ≥20 and ≤40 kg/m2.
✓. Female patients who are non-childbearing potential (surgically sterile \[hysterectomy\]) or post-menopausal ≥2 years; or non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide, or intrauterine device) from Screening until the End-of-Study visit.
✓. No clinically significant abnormal laboratory values.
✓. No clinically significant findings in the 12-lead ECG.
✓. No clinically significant findings from a vital signs measurement.

✕. Unwilling to provide genotyping (phenotyping) sample for CYP2D6.
✕. Have known or suspected carcinoma.
✕. Have known presence or history of renal or hepatic insufficiency.
✕. Have known history, hypersensitivity or clinically significant idiosyncratic reaction to risperidone, paliperidone, and/or any other drug substance with similar activity.
✕. Have a history of alcohol or drug-dependence as per DSM-V criteria during the 6-month period immediately prior to Screening.
✕. Have a history of epilepsy or risk of having seizures.
✕. Are pregnant, lactating, or likely to become pregnant during the study.
✕. Have taken an antipsychotic depot product (including investigational products) within the 60 days prior to Screening.