Effects of Food on the Bioavailability and Pharmacokinetic Profile of Itasetron After a Single Oral Dose in Healthy Male Subjects

Study Overview
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Brief Summary
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food interaction, pharmacokinetics, safety and tolerability

Official Title
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Investigation of the Effects of Food on the Bioavailability and Pharmacokinetic Profile of Itasetron After a Single Oral Dose of 1 mg in Healthy Male Subjects (3-way Cross-over)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Itasetron tablet
* Drug: Itasetron infusion
* Other: high fat breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all participants in the study will range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-index) written informed consent in accordance with Good Clinical Practica and local legislation Exclusion Criteria: Subjects will be excluded from the study if the results of the medical examination or laboratory tests are judged by the investigator to differ significantly from normal clinical values Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders Subjects with known history of orthostatic hypotension, fainting spells or blackouts Subjects with chronic or relevant acute infections Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Subjects who have taken a drug with a long half-life (>= 24 hours) within one month before enrolment in the study Subjects who received any other drugs which might influence the results of the trial during the week previous the start of the study Subjects who have participated in another study with an investigational drug within the last 2 months preceding this study Subjects who are unable to refrain from smoking on study days Subjects who smoke more than 10 cigarettes (or 3 cigars or pipes) per day Subjects who drink more than 60 g of alcohol per day Subjects who are dependent on drugs Subjects who have donated blood (>= 100 ml) within the last 4 weeks Subjects who participated in excessive physical activities (e.g. competitive sports) within the last week before the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Itasetron tablet fed<br> | Drug: Itasetron tablet<br> <br> Other: high fat breakfast<br> <br> |
| Active Comparator: Itasetron tablet fasted<br> | Drug: Itasetron tablet<br> <br> |
| Active Comparator: Itasetron infusion fasted<br> | Drug: Itasetron infusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration time curve from zero to infinity (AUC0-inf) |  | up to 48 hours after drug administration | 
| Maximum concentration of drug in plasma |  | up to 48 hours after drug administration | 
| Time to maximum concentration (tmax) |  | up to 48 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration time curve from zero to to the time of last data point above limit of quantitation (AUC0-tlast) |  | up to 48 hours after drug administration | 
| Cmax/AUC ratio |  | up to 48 hours after drug administration | 
| Mean residence time in the body (MRTtot) |  | up to 48 hours after drug administration | 
| Elimination half-life (t1/2) |  | up to 48 hours after drug administration | 
| Apparent volume of distribution during the terminal phase λz (Vz) |  | up to 48 hours after drug administration | 
| Total clearance from plasma (CLtot) |  | up to 48 hours after drug administration | 
| Apparent volume of distribution after intravascular dose at steady state (Vss) |  | up to 48 hours after drug administration | 
| Number of participants with clinically significant findings in vital signs | blood pressure, pulse rate | up to 8 days after last drug administration | 
| Number of participants with clinically significant findings in ECG |  | up to 8 days after last drug administration | 
| Number of participants with clinically significant findings in laboratory tests |  | up to 8 days after last drug administration | 
| Number of participants with adverse events |  | up to 8 days after last drug administration |