A Single Dose, Open-Label, Randomized, Two-Way Crossover Food Effect Study Comparing 12.5 mg FazaClo™ (clozapine) ODT under Fasted and Fed Conditions in Healthy Male Volunteers.
- Conditions
- Resistant schizophrenia in patientsMedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia
- Registration Number
- EUCTR2008-006738-85-GB
- Lead Sponsor
- Azur Pharma, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 24
-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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method