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HealthyPhase 1NCT02264171

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

A Phase 1 study testing Tamsulosin HCl and Ketoconazole in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 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?
Tamsulosin HCl and Ketoconazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
Apr 2008to Jun 2008
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 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

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, 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
Show all 18Show fewer
  • 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

About this study

Official title: An Open Label Randomized Two-way Crossover Study to Investigate the Effect of Ketoconazole Mediated CYP3A4 Inhibition on the Single Oral Dose Pharmacokinetics of Tamsulosin in Healthy Male Volunteers (CYP2D6 Extensive Metabolizers)

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
Being tested
Tamsulosin HCl, Ketoconazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tamsulosin HClDrug

  • KetoconazoleDrug

Study groups in NCT02264171
Study groupRoleWhat they receive
Ketoconazole + Tamsulosin HClExperimentalKetoconazole given once daily in the morning on days -3 to 2 Tamsulosin HCl given at day 1
Receives: Drug: Tamsulosin HCl; Drug: Ketoconazole
Tamsulosin HClActive comparatorTamsulosin HCl given at day 1
Receives: Drug: Tamsulosin HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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)

    Measured: up to 48 hours after dosing

Secondary outcomes (11)

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

    Measured: 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)

    Measured: up to 48 hours after dosing

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

    Measured: up to 48 hours after dosing

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

    Measured: up to 48 hours after dosing

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

    Measured: up to 48 hours after dosing

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

    Measured: 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)

    Measured: up to 48 hours after dosing

  8. Number of subjects with adverse events

    Measured: up to 21 days after last Tamsulosin administration

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

    Measured: 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)

    Measured: 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)

    Measured: up to 48 hours after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2014 (estimated)
  2. Study startApr 2008
  3. Primary completionJun 2008

Resources

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
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02264171
Sponsor's protocol ID
527.78
Status last verified
Oct 2014
First submitted
14 Oct 2014
Last updated
15 Oct 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tamsulosin HCl and Ketoconazole 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 5 inclusion and 18 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 15 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. 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?

Cmax (maximum measured concentration of Tamsulosin HCl in plasma) (time frame: up to 48 hours after dosing). 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?

On the ClinicalTrials.gov record for NCT02264171.

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 15 Oct 2014.

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