E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Resistant schizophrenia in patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039626 |
E.1.2 | Term | Schizophrenia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effect of food on the bioavailability/pharmacokinetics of FazaClo™ ODT following single doses in the same fasted and fed subjects. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 2 |