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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Itasetron tablet; Drug: Itasetron infusion; Other: high fat breakfast

• Registration Number: NCT02259985
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

food interaction, pharmacokinetics, safety and tolerability

Detailed Description

Not available

Study Timeline

• Study Start: 1998-03
• Primary Completion: 1998-05
• Status Verified: 2014-10
• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-07
• Last Update Submitted: 2014-10-07
• Study First Posted: 2014-10-09
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Itasetron tablet fed	Itasetron tablet	-
Itasetron tablet fed	high fat breakfast	-
Itasetron tablet fasted	Itasetron tablet	-
Itasetron infusion fasted	Itasetron infusion	-

Primary Outcome Measures

Name	Time	Method
Time to maximum concentration (tmax)	up to 48 hours after drug administration
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

Secondary Outcome Measures

Name	Time	Method
Number of participants with clinically significant findings in laboratory tests	up to 8 days after last drug administration
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
Apparent volume of distribution during the terminal phase λz (Vz)	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
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	up to 8 days after last drug administration	blood pressure, pulse rate
Number of participants with clinically significant findings in ECG	up to 8 days after last drug administration
Number of participants with adverse events	up to 8 days after last drug administration