HealthyPhase 1NCT02269202
Pharmacokinetics of Midazolam, With and Without Concomitant Administration of Crobenetine in Healthy Male Subjects
A Phase 1 study testing Midazolam, tablet and Crobenetine, i.v. infusion in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess the pharmacokinetics of midazolam with/without concomitant administration of crobenetine 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?
- Midazolam, tablet and Crobenetine, i.v. infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Apr 2002
- 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 should be healthy males, range from 21 to 50 years of age and their bodymass index (BMI) be within 18.5 to 29.9 kg/m2
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy), which is deemed relevant to the trial as judged by the investigator
Show all 16Show fewer
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study (except substitution therapy regarding thyroid gland)
- Use of any drugs that might influence the results of the trial (within one week prior to administration or during the trial)
- Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (≥ 100 mL, within four weeks prior to administration or during the trial)
- Excessive physical activities (within the last week before the study)
- Any laboratory value outside the reference range of clinical relevance
About this study
Official title: Pharmacokinetics of 7.5 mg Midazolam, Given Orally With and Without Concomitant Administration of 175 mg Crobenetine, Given as a 6 Hrs i.v. Infusion (One Hour Loading Dose Directly Followed by a Five Hours Maintenance Dose). A Randomised, Single Blind, Two-way Crossover Trial in Healthy Male Subjects
To assess the pharmacokinetics of midazolam with/without concomitant administration of crobenetine
- Conditions
- Healthy
- Being tested
- Midazolam, tablet, Crobenetine, i.v. infusion, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam, tabletDrug
Crobenetine, i.v. infusionDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Midazolam and crobenetine | Experimental | Not described Receives: Drug: Midazolam, tablet; Drug: Crobenetine, i.v. infusion |
| Midazolam and placebo | Placebo comparator | Not described Receives: Drug: Midazolam, tablet; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of midazolam from zero time extrapolated to infinity (AUC0-infinity)
Measured: up to 24 hours after start of drug administration
Maximum observed concentration of midazolam in plasma (Cmax)
Measured: up to 24 hours after start of drug administration
Secondary outcomes (14)
Area under the concentration-time curve (AUC)
Measured: up to 24 hours after start of drug administration
Time to maximum observed concentration (tmax)
Measured: up to 24 hours after start of drug administration
Individual time courses of plasma concentrations
Measured: up to 24 hours after start of drug administration
Terminal rate constant in plasma (λz)
Measured: up to 24 hours after start of drug administration
Terminal half-life in plasma (t1/2)
Measured: up to 24 hours after start of drug administration
Mean residence time in the body (MRT)
Measured: up to 24 hours after start of drug administration
Apparent clearance in plasma (CL/F)
Measured: up to 24 hours after start of drug administration
Volume of distribution (V)
Measured: up to 24 hours after start of drug administration
Changes from baseline in physical examination
Measured: pre-dose and day 8 after drug administration
Number of patients with clinically relevant findings in vital signs
blood pressure, pulse rate
Measured: up to day 8 after drug administration
Number of patients with clinically relevant findings in 12-lead ECG
Measured: up to day 8 after drug administration
Number of patients with clinically relevant findings in laboratory tests
Measured: up to day 8 after drug administration
Number of patients with adverse events
Measured: up to day 8 after drug administration
Global assessment of tolerability by the investigator on a 4-point rating scale
Measured: up to 192 hours after start of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startFeb 2002
- Primary completionApr 2002
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
- Masking
- Single blind
- Enrolment
- 20 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
- NCT02269202
- Sponsor's protocol ID
- 599.12
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of 7.5 mg Midazolam, Given Orally With and Without Concomitant Administration of 175 mg Crobenetine, Given as a 6 Hrs i.v. Infusion (One Hour Loading Dose Directly Followed by a Five Hours Maintenance Dose). A Randomised, Single Blind, Two-way Crossover Trial in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02269202
- Acronym / sponsor ID
- 599.12
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Apr 2002 (actual)
- First posted
- 21 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.
To assess the pharmacokinetics of midazolam with/without concomitant administration of crobenetine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam and crobenetine | Experimental | Drug: Midazolam, tablet, Drug: Crobenetine, i.v. infusion |
| Midazolam and placebo | Placebo comparator | Drug: Midazolam, tablet, Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All participants in the study should be healthy males, range from 21 to 50 years of age and their bodymass index (BMI) be within 18.5 to 29.9 kg/m2
Key exclusion criteria (16 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- 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 |
|---|---|---|
| Midazolam, tablet | Drug | Midazolam and crobenetine, Midazolam and placebo |
| Crobenetine, i.v. infusion | Drug | Midazolam and crobenetine |
| Placebo | Drug | Midazolam and placebo |
Primary outcome
Area under the concentration-time curve of midazolam from zero time extrapolated to infinity (AUC0-infinity)
Time frame: up to 24 hours after start of drug administration
Maximum observed concentration of midazolam in plasma (Cmax)
Time frame: up to 24 hours after start of drug administration
14 secondary outcomes
Area under the concentration-time curve (AUC)
Time frame: up to 24 hours after start of drug administration
Time to maximum observed concentration (tmax)
Time frame: up to 24 hours after start of drug administration
Individual time courses of plasma concentrations
Time frame: up to 24 hours after start of drug administration
Terminal rate constant in plasma (λz)
Time frame: up to 24 hours after start of drug administration
Terminal half-life in plasma (t1/2)
Time frame: up to 24 hours after start of drug administration
Mean residence time in the body (MRT)
Time frame: up to 24 hours after start of drug administration
Apparent clearance in plasma (CL/F)
Time frame: up to 24 hours after start of drug administration
Volume of distribution (V)
Time frame: up to 24 hours after start of drug administration
Changes from baseline in physical examination
Time frame: pre-dose and day 8 after drug administration
Number of patients with clinically relevant findings in vital signs
Time frame: up to day 8 after drug administration
Number of patients with clinically relevant findings in 12-lead ECG
Time frame: up to day 8 after drug administration
Number of patients with clinically relevant findings in laboratory tests
Time frame: up to day 8 after drug administration
Number of patients with adverse events
Time frame: up to day 8 after drug administration
Global assessment of tolerability by the investigator on a 4-point rating scale
Time frame: up to 192 hours after start of 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 21 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 Midazolam, tablet and Crobenetine, i.v. infusion 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 1 inclusion and 16 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 21 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. Some participants in this study may receive a placebo. 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 of midazolam from zero time extrapolated to infinity (AUC0-infinity) (time frame: up to 24 hours after start of drug administration). The study lists 2 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 21 Oct 2014.