Clinical trial NCT02259985: Effects of Food on the Bioavailability and Pharmacokinetic Profile of Itasetron After a Single Oral Dose in Healthy Male Subjects
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 15
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: food interaction, pharmacokinetics, safety and tolerability


Eligibility criteria: 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

Primary outcomes:
measure: Area under the concentration time curve from zero to infinity (AUC0-inf)
timeFrame: up to 48 hours after drug administration
measure: Maximum concentration of drug in plasma
timeFrame: up to 48 hours after drug administration
measure: Time to maximum concentration (tmax)
timeFrame: up to 48 hours after drug administration
Secondary outcomes:
measure: Area under the concentration time curve from zero to to the time of last data point above limit of quantitation (AUC0-tlast)
timeFrame: up to 48 hours after drug administration
measure: Cmax/AUC ratio
timeFrame: up to 48 hours after drug administration
measure: Mean residence time in the body (MRTtot)
timeFrame: up to 48 hours after drug administration
measure: Elimination half-life (t1/2)
timeFrame: up to 48 hours after drug administration
measure: Apparent volume of distribution during the terminal phase λz (Vz)
timeFrame: up to 48 hours after drug administration
measure: Total clearance from plasma (CLtot)
timeFrame: up to 48 hours after drug administration
measure: Apparent volume of distribution after intravascular dose at steady state (Vss)
timeFrame: up to 48 hours after drug administration
measure: Number of participants with clinically significant findings in vital signs
timeFrame: up to 8 days after last drug administration
measure: Number of participants with clinically significant findings in ECG
timeFrame: up to 8 days after last drug administration
measure: Number of participants with clinically significant findings in laboratory tests
timeFrame: up to 8 days after last drug administration
measure: Number of participants with adverse events
timeFrame: up to 8 days after last drug administration
Other outcomes:
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