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

NCT02259985 | Completed Phase 1

• 1 other identifier: 208.629
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

food interaction, pharmacokinetics, safety and tolerability

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

Study Arms (3)

Itasetron tablet fed

EXPERIMENTAL

Drug: Itasetron tablet; Other: high fat breakfast

Itasetron tablet fasted

ACTIVE COMPARATOR

Drug: Itasetron tablet

Itasetron infusion fasted

ACTIVE COMPARATOR

Drug: Itasetron infusion

Interventions

Itasetron tablet DRUG

Itasetron tablet fasted; Itasetron tablet fed

Itasetron infusion DRUG

Itasetron infusion fasted

high fat breakfast OTHER

Itasetron tablet fed

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

itasetron

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 9, 2014
• Study Start: March 1, 1998
• Primary Completion: May 1, 1998
• Last Updated: October 9, 2014

Record last verified: 2014-10