Clinical trial NCT02273466: Pharmacokinetics of Oral Desipramine With and Without Concomitant Administration of Crobenetine Infusion in Healthy Male Subjects
Official title: Pharmacokinetics of 50 mg Desipramine Daily, Given Orally Over 7 Days 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 Randomized, Placebo Controlled, Single Blind (for Crobenetine), Two-way Cross Over Trial in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 24
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the steady state pharmacokinetics of Desipramine with/without concomitant administration of Crobenetine.


Eligibility criteria: Inclusion Criteria:

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.

In accordance with Good Clinical Practice and local legislation all volunteers will have given their written informed consent prior to admission to the study.

Exclusion Criteria:

* 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
* 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
* Use of any drugs which 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
* Cytochrome P450 2D6 poor metaboliser (to be determined by phenotyping or genotyping)

Primary outcomes:
measure: Area under the concentration time curve for desipramine at steady state (AUC,ss)
timeFrame: up to 168 hours after start of drug administration
measure: Maximum plasma concentration of desipramine at steady state (Cmax,ss)
timeFrame: up to 168 hours after start of drug administration
Secondary outcomes:
measure: Individual time courses of plasma concentrations
timeFrame: up to 168 hours after start of drug administration
measure: Area under the concentration time curve from zero time to time of last quantifiable drug concentration (AUC0-tz)
timeFrame: up to 168 hours after start of drug administration
measure: Area under the concentration time curve from zero time extrapolated to infinity(AUC0-infinity)
timeFrame: up to 168 hours after start of drug administration
measure: Time to reach maximum concentration of desipramine at steady state (tmax,ss)
timeFrame: up to 168 hours after start of drug administration
measure: Apparent terminal rate constant (λz)
timeFrame: up to 168 hours after start of drug administration
measure: Apparent terminal half-live in plasma (t1/2)
timeFrame: up to 168 hours after start of drug administration
measure: Mean residence time (MRT)
timeFrame: up to 168 hours after start of drug administration
measure: Total clearance (CL)
timeFrame: up to 168 hours after start of drug administration
measure: Apparent volume of distribution (V)
timeFrame: up to 168 hours after start of drug administration
measure: Observed concentration of crobenetine (C,h)
timeFrame: 1 and 6 hours after start of infusion
measure: Number of subjects with adverse events
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in vital signs
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in 12-lead ECG
timeFrame: up to 8 days after last drug administration
measure: Number of subjects with clinically significant findings in laboratory tests
timeFrame: up to 8 days after last drug administration
Other outcomes:
Locations:
Study officials:
References: