CClinicalTrials.gg
Sign In
CompletedNCT02264171Updated Oct 15, 2014

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

A Phase 1 interventional study of Tamsulosin HCl and Ketoconazole in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-15.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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, 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
  • Excessive physical activities within the last week before the trial or during the trial
  • Hypersensitivity to treatment medication and/or related drugs of these classes
  • Non extensive metabolizer (EM) for CYP2D6
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Ketoconazole + Tamsulosin HCl

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

    Drug: Tamsulosin HCl · Drug: Ketoconazole

  • Active comparator
    Tamsulosin HCl

    Tamsulosin HCl given at day 1

    Drug: Tamsulosin HCl

Interventions

  • DrugTamsulosin HCl
  • DrugKetoconazole
06

What researchers measure

Primary outcomes

  1. Cmax (maximum measured concentration of Tamsulosin HCl in plasma)

    Time frame: up to 48 hours after dosing

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

    Time frame: up to 48 hours after dosing

Secondary outcomes

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

    Time frame: up to 48 hours after dosing

  2. 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)

    Time frame: up to 48 hours after dosing

  3. λz (terminal rate constant of Tamsulosin HCl in plasma)

    Time frame: up to 48 hours after dosing

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

    Time frame: up to 48 hours after dosing

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

    Time frame: up to 48 hours after dosing

  6. CL/F (apparent clearance of the analyte in the plasma after extravascular administration)

    Time frame: up to 48 hours after dosing

  7. Vz/F (apparent volume of distribution of Tamsulosin HCl during the terminal phase λz following an extravascular dose)

    Time frame: up to 48 hours after dosing

  8. Number of subjects with adverse events

    Time frame: up to 21 days after last Tamsulosin administration

  9. Assessment of tolerability by investigator on a 4-point scale

    Time frame: within 21 days after last Tamsulosin administration

  10. Ratio of the Cmax value of the Test treatment to the Cmax value of the Reference treatment after single dose (RCmax,T/R)

    Time frame: up to 48 hours after dosing

  11. Ratio of the Test treatment versus the Reference treatment from zero to infinity, expressed as ratio of AUC values after single dose (RAUC0-∞,T/R)

    Time frame: up to 48 hours after dosing

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02264171
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 15, 2014
Start date
Apr 2008
Primary completion
Jun 2008
Last update
Oct 15, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Boehringer Ingelheim

Start the discussion