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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: high fat breakfast; Drug: Itasetron tablet; Drug: Itasetron infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02259985

208.629

Details and patient eligibility

About

food interaction, pharmacokinetics, safety and tolerability

Enrollment: 15 patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Itasetron tablet fed

Experimental group

Treatment:

Drug: Itasetron tablet

Other: high fat breakfast

Itasetron tablet fasted

Active Comparator group

Treatment:

Drug: Itasetron tablet

Itasetron infusion fasted

Active Comparator group

Treatment:

Drug: Itasetron infusion