Resistant schizophrenia in patients MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Trade Name: FazaClo™
Pharmaceutical Form: Dispersible tablet
Other descriptive name: Clozapine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Sponsors
Azur Pharma, Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Adult males aged 18-45 years inclusive and between 19-30 kg/m2 body mass index. -Subjects who are healthy as determined by pre-study medical history, physical examination, 12 Lead ECG (QTc upper limit 430 ms), 24 hour Holter ECG monitoring (screening) and EEG (screening). -Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator. -Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening. -Subjects who are negative for drugs of abuse and alcohol tests at screening and admission. -Subjects who are non-smokers for at least 3 months preceding screening. -Subjects who are able and willing to give written informed consent. -Medical history must be verified by either a personal physician or medical practitioner as appropriate. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Subjects who do not conform to the above inclusion criteria. -Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders. -Subjects who have a clinically relevant surgical history. -Subjects who have a clinically relevant family history including a history of cardiomyopathy and /or QT prolongation in first degree relatives. -Subjects who have a history of relevant atopy. -Subjects who have a history of relevant drug hypersensitivity. -Subjects who have a history of alcoholism. -Subjects who have a history of drug abuse. -Subjects who consume more than 21 units of alcohol a week. (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer). -Subjects who have a significant infection or known inflammatory process on screening. -Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhoea, heartburn). -Subjects who have an acute infection such as influenza at the time of screening or admission. -Subjects who have used prescription drugs within 4 weeks of first dosing. -Subjects who have used over the counter medication excluding routine vitamins but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor. -Subjects who have used any investigational drug in any clinical trial within 3 months of receiving the last dose. -Subjects who have received the last dose of investigational medicinal product (IMP) greater than 3 months ago but who are on extended follow-up. -Subjects who are vegetarians, vegans or have medical dietary restrictions. -Subjects who have a total white blood cell (WBC) count below 4.0 x109/L or an absolute neutrophil count below 2.5 x109/L. -Subjects who have a history or family history of glaucoma. -Subjects who cannot communicate reliably with the Investigator. -Subjects who are unlikely to co-operate with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of food on the bioavailability/pharmacokinetics of FazaClo™ ODT following single doses in the same fasted and fed subjects.;Secondary Objective: ;Primary end point(s): Assess the effect of food on the bioavailability/pharmacokinetics of FazaClo ODT following single doses in the same fasted and fed subjects. | — |
Countries
United Kingdom
Outcome results
None listed