The study will be conducted in 42 healthy volunteers
Conditions
Interventions
Trade Name: ZYPREXA - Tabletten ueberzogen 10 mg
Product Name: ZYPREXA - Tabletten ueberzogen 10 mg
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Capsule*
Route of administrat
Sponsors
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Male • Healthy, defined as absence of relevant diseases • Caucasian • Aged 18-45 years • BMI: 18-25 kg/m2 • Signed informed consent • No signs of impaired glucose tolerance as evaluated by OGTT before study inclusion during screening, normal total cholesterol, HDL, LDL, triglycerides, normal function of the thyroid. No personal or family history (parents and siblings) of diabetes or other metabolic and relevant diseases as defined by the investigator • No indication for psychiatric diseases assessed by structured clinical interview (Mini-International Neuropsychiatric Interview (MINI) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Personal or family history (parents and siblings) of diabetes or other metabolic diseases, relevant diseases as defined by the investigator • History of hypertension, RR > 140/90 at screening, cardiovascular disease • Body mass index out of the range of 25 kg/m • HIV or Hepatitis B/C positive virology • Allergy or hypersensitivity against olanzapin/ziprasidon or another excipient • Contraindications against the use of the drug according to the SmPC • Any drug intake 2 weeks prior to first study day • History of excessive bleeding tendency / hemophilia • Presence of relevant illness within the last 3 weeks • Suspected non-compliance with study instructions and life-style requirements • History of alcohol or drug abuse • Blood/Plasma donation within 4 weeks prior to study day • Previous exposure to antipsychotic drugs • Nicotine consumption at time of enrolment (at least 3 months of non-smoking required)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Definition of a set of genes relevant for glucose metabolism regulation based on gene expression data. Comparison of gene expression profiles before and after administration of antipsychotics. Association of adipokine, hormone and biomarker blood levels with gene expression profiles. Differences in body weight under olanzapine or ziprasidone medication ;Primary end point(s): gene expression profiles in skeletal muscle and adipose tissue in response to drug treatment with two different antipsychotics;Main Objective: Differences in the soft tissue gene expression profile after administration of olanzapine or ziprasidone after single and multiple dose administration. | — |
Countries
Austria
Outcome results
None listed