Effects of Food on the Bioavailability and Pharmacokineti... | NCT02259985

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

NCT02259985

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Oct 9, 2014Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Itasetron tablet
Itasetron infusion
high fat breakfast

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1998

Primary Completion Date

May 1998Actual

Completion Date

Not provided

First Submitted Date

Oct 7, 2014

First Submission Date that Met QC Criteria

Oct 7, 2014

First Posted Date

Oct 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2014

Last Update Posted Date

Oct 9, 2014Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Itasetron tablet	Drug		Itasetron tablet fasted Itasetron tablet fed
Itasetron infusion

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided