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CompletedNCT02259933Updated Oct 9, 2014

Safety, Tolerability and Pharmacokinetics of KUC 7483 CL Tablets in Healthy Male Volunteers

A Phase 1 interventional study of KUC 7483 CL and Placebo in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-09.

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

Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
Male
01

Study summary

Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated dosing

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

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04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy males according to the following criteria:

    Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

    • No finding deviating from normal and of clinical relevance
    • No evidence of a clinically relevant concomitant disease
  2. Age ≥21 and Age ≤60 years
  3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion criteria

Exclusion Criteria:

  1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  3. History of relevant orthostatic hypotension, fainting spells or blackouts
  4. Chronic or relevant acute infections
  5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  6. Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  7. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  8. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  9. Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
  10. Inability to refrain from smoking on trial days
  11. Alcohol abuse (more than 60 g/day)
  12. Drug abuse
  13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  14. Excessive physical activities (within one week prior to administration or during the trial)
  15. Any laboratory value outside the reference range of clinical relevance
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
35 participants (actual)

Study arms

  • Experimental
    KUC 7483 CL

    increasing repeated oral doses

    Drug: KUC 7483 CL

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Number of subjects with abnormal findings in physical examination

    Time frame: up to 8 days after last drug administration

  2. Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)

    Time frame: up to 8 days after last drug administration

  3. Number of subjects with clinically significant changes in vital signs

    Blood Pressure, Pulse Rate, body temperature, orthostatic testing

    Time frame: up to 8 days after last drug administration

  4. Number of subjects with clinically significant changes in laboratory tests

    Time frame: up to 8 days after last drug administration

  5. Changes in salivary secretion

    Time frame: pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7

  6. Changes in residual urine volume

    Time frame: pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7

  7. Number of subjects with adverse events

    Time frame: up to 8 days after last drug administration

  8. Assessment of tolerability by investigator on a 5-point scale

    Time frame: within 8 days after last drug administration

  9. Number of subjects with clinically significant changes in special laboratory parameters

    Tropanin I, Insulin, C-Peptide, Glucagon, free fatty acids and faecal occult blood testing, Potassium, Lactate and cAMP

    Time frame: up to day 8

Secondary outcomes

  1. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: up to day 9

  2. Time from dosing to the maximum concentration of the analyte in plasma (Tmax)

    Time frame: up to day 9

  3. Area under the concentration-time curve of the analyte in plasma (AUC)

    Time frame: up to day 9

  4. Terminal rate constant of the analyte constant in plasma (λz)

    Time frame: up to day 9

  5. Terminal half-life of the analyte in plasma (t1/2)

    Time frame: up to day 9

  6. Mean residence time of the analyte in the body after oral administration (MRTpo)

    Time frame: up to day 9

  7. Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)

    Time frame: up to day 9

  8. Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)

    Time frame: up to day 9

  9. Amount of the analyte that is eliminated in urine from the time point t1 until time point t2 (Aet1-t2)

    Time frame: up to day 9

  10. Fraction of administered drug excreted in urine from the time point t1 until time point t2 (fet1-t2)

    Time frame: up to day 9

  11. Renal clearance of the analyte determined from the time point t1 until time point t2 (CLR,t1-t2)

    Time frame: up to day 9

  12. Minimum concentration of the analyte in plasma at steady state (Cmin,ss )

    Time frame: up to day 9

  13. Accumulation ratio (RA)

    Time frame: up to day 9

  14. Linearity index (LI)

    Time frame: up to day 9

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 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02259933
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 9, 2014
Start date
Feb 2004
Primary completion
May 2004
Last update
Oct 9, 2014
View the source record on ClinicalTrials.gov ↗

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