First in Man Study of Safety, Tolerability and PK Profile of RBP-7000

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability and PK profile of a single dose of 60mg RBO-7000 in stable subjects with schizophrenia who are on medication other than risperidone.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indivior Inc.

Criteria

Inclusion Criteria:

• Confirmed diagnosis of paranoid, residual, or undifferentiated schizophrenia in a documented letter from the subject's psychiatrist or primary care provider.

• Clinically stable subjects (subjects whom the Principal Investigator (PI) established by medical record or by history from the subject and at least one reliable informant who resides with the subject, that the subject has been clinically stable for at least 60 days without hospitalization) will be eligible to participate in the study.

• Subjects with a body mass index (BMI) of 18 to 33 kg/m2 inclusive and weighing at least 49.9 kg are eligible for entry.

• Subjects who have given written informed consent.

Exclusion Criteria:

• Subjects taking any risperidone product in the last 60 days prior to study screening.

• Subjects with a history of cancer (excluding resected basal cell or squamous cell carcinoma of the skin) unless they have been disease free for ≥ 5 years.

• Subjects with another active medical condition or organ disease that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drug. This includes, but is not limited to the following abnormalities: total bilirubin > 2.5 mg/dL (51 μmol/L), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) or clinically significant serum creatinine > 2 x ULN, international normalized ratio (INR) ≥ 2.0. Other excluded medical conditions including, but not limited to, history of heart attack, brain injury, low blood pressure and clinically significant irregular heartbeat.

• Subjects with known diagnosis of type 1 or 2 diabetes or subjects with an abnormal Hemoglobin A1c (HbA1c) at screening.

• Subjects with clinically significant co-morbidities that could affect near-term survival.

• Subjects treated with any investigational drug within 30 days beginning study screening.

• Subjects with significant traumatic injury, major surgery or open biopsy within the past 4 weeks.

• Subjects receiving opioid or opioid-containing analgesics.

• Subjects consuming > 1 alcoholic drink per day within the last 30 days (defined as one ounce of 80 proof spirits, 12 ounces of beer, or 4 ounces of wine).

• Subjects with prior allergic reactions or sensitivities to any component of RBP-7000.

• Subjects with other concurrent uncontrolled illness that may interfere with his or her ability to participate in the trial.

• Subjects with other known contraindications or sensitivity to risperidone or other components of RBP-7000.

• Women with a positive pregnancy test at screening. Women of childbearing potential, who are pregnant or lactating, seeking pregnancy, or failing to take adequate contraceptive precautions, (e.g., an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence. Should a female subject become sexually active, she must agree to use a double barrier method or barrier plus spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).

• . Subjects with a positive urine drug screen for opiates, cocaine, amphetamines, methadone, marijuana, barbiturates, benzodiazepines, methamphetamine, phencyclidine, and tricyclic antidepressants unless the positive screen is determined to be secondary to an allowable concomitant medication.

• Subjects with epilepsy or other seizure disorders, Parkinson's disease, or dementia.

• Subjects taking buproprion, chlorpheniramine, cimetidine, clomipramine, doxepin, or quinidine.

• Subjects taking clozapine, phenothiazines, or haloperidol.

• Subjects taking serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine) in the 30 days prior to beginning study screening.

• . Subjects taking medications, in addition to those listed above, which may be expected to significantly interfere with the metabolism or excretion of risperidone and/or 9-hydroxyrisperidone, that may be associated with a significant drug interaction with risperidone, or may pose a significant risk to subjects' participation in the study.

• Subjects who have been previously enrolled into the study.

• Subjects who are unable, in the opinion of the Principal Investigator, to comply fully with the study requirements.