Pharmacokinetics of Oral Desipramine With and Without Concomitant Administration of Crobenetine Infusion in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Desipramine tablet; Drug: Crobenetine infusion; Drug: Placebo infusion

• Registration Number: NCT02273466
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2002-04
• Status Verified: 2014-10
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-23
• Last Update Submitted: 2014-10-23
• Study First Posted: 2014-10-24
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Desipramine with Crobenetine	Crobenetine infusion	-
Desipramine alone	Placebo infusion	-
Desipramine alone	Desipramine tablet	-
Desipramine with Crobenetine	Desipramine tablet	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration time curve for desipramine at steady state (AUC,ss)	up to 168 hours after start of drug administration
Maximum plasma concentration of desipramine at steady state (Cmax,ss)	up to 168 hours after start of drug administration

Secondary Outcome Measures

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