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

NCT02765555 | Completed Phase 1

• 1 other identifier: RB-US-09-0007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (9)

• Incidence of treatment emergent adverse and serious adverse events after a single injection of RBP-7000

  Adverse events, serious adverse events, discontinuations due to AEs, local injection site tolerability, vital signs, physical examinations, laboratory results, use of concomitant medications, clinical symptom assessments, 12-lead ECGs

  Day 1-Day 85

• Maximum plasma concentration (Cmax) after a single injection of RBP-7000

  PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.

  Pre-Dose to 84 days post-dose

• Time of occurrence of Cmax (Tmax) after a single injection of RBP-7000

  PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.

  Pre-Dose to 84 days post-dose

• Area under the plasma concentration versus time curve (AUC) after a single injection of RBP-7000

  PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone) at initial burst, secondary peak (if applicable) and overall.

  Pre-Dose to 84 days post-dose

• AUC last after a single injection of RBP-7000

  Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).

  Day 85

• C last

  Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).

  Day 85

• T last

  Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).

  Day 85

• Apparent elimination rate constant (AUC0-∞, λz)

  Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).

  Pre-dose to 84 days post-dose

• Half life (T1/2)

  Overall PK parameter will be determined for both risperidone and total risperidone (risperidone + 9-hydroxyrisperidone).

  Pre-dose to 84 days post-dose

Secondary Outcomes (1)

• Cmax versus RISPERDAL® CONSTA® historical data

  Pre-Dose to 84 days post-dose

Study Arms (1)

RBP-7000

EXPERIMENTAL

All subjects that meet initial study entry criteria will receive a test dose of 0.25mg of oral risperidone. Subjects who continue to be eligible will return to the clinical unit in one week and receive a single dose of 60mg RBP-7000 after a 2 hour fast. Subjects will remain in the clinical unit for 14 days, then return for 10 additional weeks after discharge.

Drug: RBP-7000

Interventions

RBP-7000 DRUG

Single dose

RBP-7000

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (1)

CRI Worldwide

Willingboro, New Jersey, 08046, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 6, 2016
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 6, 2016

Record last verified: 2016-05

Locations

US (1)