Maintenance/substitution agent for the treatment of opioid dependence. MedDRA version: 16.0 Level: LLT Classification code 10012346 Term: Dependence on opiates System Organ Class: 100000004873
Conditions
Interventions
Product Name: RBP-6300 Formulation B
Pharmaceutical Form: Tablet
INN or Proposed INN: Buprenorphine Hemiadipate Hydrochloride
Current Sponsor code: RX778002A
Concentration unit: mg milligram(s)
Concen
Sponsors
Reckitt Benckiser Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject must be a male or non-pregnant, non-breastfeeding female. Subject must be between 18 and 55 years of age (inclusive) at screening. Subject’s Body Mass Index (BMI) must be between 18.5 and 30.0 kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110.23 lbs). Women of childbearing potential who agree to use adequate contraception methods (e.g., an oral or injectable hormonal contraceptive, an approved hormonal implant or topical patch, an intrauterine device, a double barrier method, or a 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). Post-menopausal status will be confirmed by a follicle stimulating hormone (FSH) test at initial screening. Male subjects of childbearing potential with partner(s) of childbearing potential must agree to take appropriate contraceptive precautions from screening until 3 months after receiving the last dose of study treatment and agree to use barrier contraception, in addition to their partner(s) using another method. Acceptable forms of contraception are as listed in criteria 4.2.4 Male subjects must refrain from donating sperm and female subjects from donating eggs for 90 days after the end of the study. Subject must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures. Subject must be willing and able to remain in the study unit for the entire duration of each confinement period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 48 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Women of childbearing potential who are pregnant, lactating, seeking pregnancy, or who do not agree to use adequate contraceptive methods. History or presence of any major health issues, including but not limited to: clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results. Clinically significant abnormal finding on the physical examination, medical history, ECG, or clinical laboratory results at screening. History or presence of allergic or adverse response to buprenorphine, naloxone, naltrexone or related drugs. Significantly abnormal diet, as determined by the PI or designee, during the 4 weeks preceding the first dose of study medication. Blood or plasma donation within 3 months prior to the first dose of study medication. Participation in another clinical trial (i.e., randomized subjects who received study medication) within 3 months prior to the first dose of study medication. Use of any over-the-counter (OTC) medication, including herbal and nutritional supplements, or grapefruit juice within 7 days prior to the first dose of study medication. Use of any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication. Treated with any known drugs that are moderate or strong inhibitors/inducers of CYP3A4 enzyme such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication. Appendix 4 contains a list of CYP3A4 inhibitors/inducers. Use of tobacco or nicotine containing products within 60 days prior to the first dose of study medication and during the duration of the trial period, or testing positive for Cotinine. Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates, including buprenorphine) or any history of intravenous drug abuse or any history of abuse of opioids. Positive urine screen for ethanol. Positive results for human immunodeficiency virus (HIV-1 or HIV-2 antibodies by ELISA or EIA and reactive/positive results confirmed by HIV specific immunobloting or immunoprecipitation assays), hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), hepatitis B core antibodies (IgG anti-HBc or IgM anti-HBc) unless antibodies to HBsAg are positive in isolation, consistent with hepatitis B vaccination, hepatitis C antibody (anti-HCV), or hepatitis C viral RNA as assessed by PCR. Hemoglobin at screening of < 11.5 g/dl (if female subject) or < 12.5 g/dl (if male subject). Subject has, or has a history of, any significant disease, surgery or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the relative bioavailability of buprenorphine after oral administration of RBP 6300 (Formualtion A) 10 mg as compared to RBP 6300 (Formualtion B) 10 mg, when administered in the fasted state. To assess the relative bioavailability of buprenorphine after oral administration of RBP 6300 (Formulation A) 10 mg to subjects who have been fed a high-fat breakfast as compared to fasted. ;Secondary Objective: To assess the safety and tolerability of RBP 6300 (Formulation A) and RBP 6300 (Formulation B) administered to healthy subjects under a naltrexone blockade. To assess the plasma PK of naloxone, naloxone-3-glucuronide, buprenorphine, buprenorphine hemiadipate and norbuprenorphine after oral administration of RBP 6300 (Formulation A) 10 mg as compared to RBP 6300 (Formulation B) 10 mg, when administered in the fasted state. To assess the plasma PK of naloxone, naloxone-3-glucuronide, buprenorphine, buprenorphine hemiadipate and norbuprenorphine after oral administration of RBP 6300 (Formulation A) 10 mg to subjects who have been fed a high-fat breakfast as compared to fasted. ;Primary end point(s): Pre-treatment AEs will be listed by subject. TEAEs will be listed and tabulated by treatment and by severity and causal relationship to study treatment. SAEs will be listed separately. Individual vital signs (supine BP, heart rate, respiration rate, oxygen saturation and aural temperature) will be listed per treatment and measurement time and summarised descriptively. ECG assessments will be listed by subject and measurement time. Individual clinical laboratory results (haematology, biochemistry and urinalysis) will be listed by subject and measurement time, including laboratory comments. Abnormal clinical laboratory values and associated repeats will be listed by subject and measurement time separately together with comments as to their clinical significance. A summary of the number of occurrences of abnormal clinical laboratory parameters will | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Safety Endpoints Clinical laboratory results. 12-lead ECG. Concomitant medication assessment;Timepoint(s) of evaluation of this end point: Clinical laboratory results - Prior First dose and 5 to 10 days after final dose. 12-lead ECG - Prior first dose and 5 -10 days post final dose. Concomitant medication assessment - Prior initial dose administration, every day until 5 -10 days post final dose. | — |
Countries
United Kingdom
Contacts
Public ContactMark Hood
Reckitt Benckiser Pharmaceuticals Limited
Outcome results
None listed