A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients… (NCT01592110) | Clinical Trial Compass
CompletedPhase 1
A Safety and PK Study of Injectable Risperidone-SABER and the DosePro Delivery System in Patients With Schizophrenia
United States40 participantsStarted 2012-07
Plain-language summary
This is a Phase 1, open-label study to evaluate the safety and pharmacokinetics (PK) of three doses of risperidone-SABER, administered with a needle and syringe or via the DosePro Needle-Free Delivery System in patients with chronic, stable schizophrenia.
Who can participate
Age range18 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.
Inclusion Criteria:
* Male or female patients 18 years of age or older.
* Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder as per DSM-IV criteria in the past 6 months or more, dependent on diagnosis.
* Currently on maintenance antipsychotic medication (i.e., 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) (kg/m2) ≥ 20 and ≤ 40.
* Female patients with:
* 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 electrocardiogram (ECG).
* No clinically significant findings from a vital signs measurement.
* Be informed of the nature of the study and give written consent prior to initiating any study procedure.
Exclusion Criteria:
* Have known or suspected carcinoma.
* Have known presence or history of renal or hepatic insufficiency.
* Have known history, hypersensitivity or idiosyncratic reaction (including dystonias) to risperidone, paliperidone, and/or any other drug…
What they're measuring
1
Number and percent of patients experiencing a treatment emergent adverse event following a single dose of risperidone-SABER
Timeframe: Within 35 days post-dose
2
Maximum plasma concentration, time of maximum plasma concentration and area under the concentration time curve for risperidone, 9-OH risperidone and active moiety (risperidone + 9-OH risperidone)