Study to Investigate the Effect of Ketoconazole Mediated CYP3A4 Inhibition on Pharmacokinetics of Tamsulosin in Healthy Male Volunteers

NCT02264171 | Completed Phase 1

• 1 other identifier: 527.78
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the effect of CYP3A4 inhibition by ketoconazole on the single oral dose pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax (maximum measured concentration of Tamsulosin HCl in plasma)

  up to 48 hours after dosing

• AUC0-∞ (Area under the concentration-time curve of Tamsulosin HCl in plasma over the time interval from 0 extrapolated to infinity)

  up to 48 hours after dosing

Secondary Outcomes (11)

• tmax (time from dosing to the maximum concentration of Tamsulosin HCl in plasma)

  up to 48 hours after dosing

• AUC0-tz (area under the concentration-time curve of Tamsulosin HCl in plasma over the time interval from 0 to the last quantifiable data point)

  up to 48 hours after dosing

• λz (terminal rate constant of Tamsulosin HCl in plasma)

  up to 48 hours after dosing

• t1/2 (terminal half-life of Tamsulosin HCl in plasma)

  up to 48 hours after dosing

• MRTpo (mean residence time Tamsulosin HCl in the body after oral administration)

  up to 48 hours after dosing

Study Arms (2)

Ketoconazole + Tamsulosin HCl

EXPERIMENTAL

Ketoconazole given once daily in the morning on days -3 to 2 Tamsulosin HCl given at day 1

Drug: Tamsulosin HCl; Drug: Ketoconazole

Tamsulosin HCl

ACTIVE COMPARATOR

Tamsulosin HCl given at day 1

Drug: Tamsulosin HCl

Interventions

Tamsulosin HCl DRUG

Ketoconazole + Tamsulosin HCl; Tamsulosin HCl

Ketoconazole DRUG

Ketoconazole + Tamsulosin HCl

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All participants in the study will be
• Healthy males
• Ranging from 21 to 50 years of age
• Body mass index (BMI) within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)
• In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

You may not qualify if:

• 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, clinically relevant electrolyte disturbances
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or clinically 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 (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
• Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
• Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
• Smoker (\> 10 cigarettes or \> 3 cigars of \> 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)
• Any laboratory value outside the reference range if indicative of underlying disease or poor health

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Tamsulosin; Ketoconazole

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 15, 2014
• Study Start: April 1, 2008
• Primary Completion: June 1, 2008
• Last Updated: October 15, 2014

Record last verified: 2014-10