HealthyPhase 1NCT02259985
Effects of Food on the Bioavailability and Pharmacokinetic Profile of Itasetron After a Single Oral Dose in Healthy Male Subjects
A Phase 1 study testing Itasetron tablet, Itasetron infusion and high fat breakfast in people with Healthy, run by Boehringer Ingelheim.
Trial summary
food interaction, pharmacokinetics, safety and tolerability Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Itasetron tablet, Itasetron infusion and high fat breakfast
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 1998to May 1998
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
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)
food interaction, pharmacokinetics, safety and tolerability
- Conditions
- Healthy
- Being tested
- Itasetron tablet, Itasetron infusion, high fat breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itasetron tabletDrug
Itasetron infusionDrug
high fat breakfastOther
| Study group | Role | What they receive |
|---|---|---|
| Itasetron tablet fed | Experimental | Not described Receives: Drug: Itasetron tablet; Other: high fat breakfast |
| Itasetron tablet fasted | Active comparator | Not described Receives: Drug: Itasetron tablet |
| Itasetron infusion fasted | Active comparator | Not described Receives: Drug: Itasetron infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve from zero to infinity (AUC0-inf)
Measured: up to 48 hours after drug administration
Maximum concentration of drug in plasma
Measured: up to 48 hours after drug administration
Time to maximum concentration (tmax)
Measured: 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)
Measured: up to 48 hours after drug administration
Cmax/AUC ratio
Measured: up to 48 hours after drug administration
Mean residence time in the body (MRTtot)
Measured: up to 48 hours after drug administration
Elimination half-life (t1/2)
Measured: up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase λz (Vz)
Measured: up to 48 hours after drug administration
Total clearance from plasma (CLtot)
Measured: up to 48 hours after drug administration
Apparent volume of distribution after intravascular dose at steady state (Vss)
Measured: up to 48 hours after drug administration
Number of participants with clinically significant findings in vital signs
blood pressure, pulse rate
Measured: up to 8 days after last drug administration
Number of participants with clinically significant findings in ECG
Measured: up to 8 days after last drug administration
Number of participants with clinically significant findings in laboratory tests
Measured: up to 8 days after last drug administration
Number of participants with adverse events
Measured: up to 8 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startMar 1998
- Primary completionMay 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259985
- Sponsor's protocol ID
- 208.629
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02259985
- Acronym / sponsor ID
- 208.629
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 1998
- Primary completion
- May 1998 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
food interaction, pharmacokinetics, safety and tolerability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itasetron tablet | Drug | Itasetron tablet fasted, Itasetron tablet fed |
| Itasetron infusion | Drug | Itasetron infusion fasted |
| high fat breakfast | Other | Itasetron tablet fed |
Primary outcome
Area under the concentration time curve from zero to infinity (AUC0-inf)
Time frame: up to 48 hours after drug administration
Maximum concentration of drug in plasma
Time frame: up to 48 hours after drug administration
Time to maximum concentration (tmax)
Time frame: up to 48 hours after drug administration
11 secondary outcomes
Area under the concentration time curve from zero to to the time of last data point above limit of quantitation (AUC0-tlast)
Time frame: up to 48 hours after drug administration
Cmax/AUC ratio
Time frame: up to 48 hours after drug administration
Mean residence time in the body (MRTtot)
Time frame: up to 48 hours after drug administration
Elimination half-life (t1/2)
Time frame: up to 48 hours after drug administration
Apparent volume of distribution during the terminal phase λz (Vz)
Time frame: up to 48 hours after drug administration
Total clearance from plasma (CLtot)
Time frame: up to 48 hours after drug administration
Apparent volume of distribution after intravascular dose at steady state (Vss)
Time frame: up to 48 hours after drug administration
Number of participants with clinically significant findings in vital signs
Time frame: up to 8 days after last drug administration
Number of participants with clinically significant findings in ECG
Time frame: up to 8 days after last drug administration
Number of participants with clinically significant findings in laboratory tests
Time frame: up to 8 days after last drug administration
Number of participants with adverse events
Time frame: up to 8 days after last drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Itasetron tablet, Itasetron infusion and high fat breakfast in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration time curve from zero to infinity (AUC0-inf) (time frame: up to 48 hours after drug administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.