HealthyPhase 1NCT02259933
Safety, Tolerability and Pharmacokinetics of KUC 7483 CL Tablets in Healthy Male Volunteers
A Phase 1 study testing KUC 7483 CL in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated dosing Read more about this study
- Who is it for?
- Ages 21 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- KUC 7483 CL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to May 2004
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Age ≥21 and Age ≤60 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Who cannot join
- 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 10 half-lives of the respective drug prior to administration or during the trial
Show all 15Show fewer
- 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
- 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 (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range of clinical relevance
About this study
Official title: A Double-blind (at Each Dose Level), Randomised, Placebo Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of KUC 7483 CL Tablets (Dosage: 40, 120, 180 mg b.i.d.) Over 7 Days in Healthy Male Volunteers
Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated dosing
- Conditions
- Healthy
- Being tested
- KUC 7483 CL, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KUC 7483 CLDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KUC 7483 CL | Experimental | increasing repeated oral doses Receives: Drug: KUC 7483 CL |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with abnormal findings in physical examination
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant changes in vital signs
Blood Pressure, Pulse Rate, body temperature, orthostatic testing
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant changes in laboratory tests
Measured: up to 8 days after last drug administration
Changes in salivary secretion
Measured: pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7
Changes in residual urine volume
Measured: pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7
Number of subjects with adverse events
Measured: up to 8 days after last drug administration
Assessment of tolerability by investigator on a 5-point scale
Measured: within 8 days after last drug administration
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
Measured: up to day 8
Secondary outcomes (14)
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: up to day 9
Time from dosing to the maximum concentration of the analyte in plasma (Tmax)
Measured: up to day 9
Area under the concentration-time curve of the analyte in plasma (AUC)
Measured: up to day 9
Terminal rate constant of the analyte constant in plasma (λz)
Measured: up to day 9
Terminal half-life of the analyte in plasma (t1/2)
Measured: up to day 9
Mean residence time of the analyte in the body after oral administration (MRTpo)
Measured: up to day 9
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Measured: up to day 9
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Measured: up to day 9
Amount of the analyte that is eliminated in urine from the time point t1 until time point t2 (Aet1-t2)
Measured: up to day 9
Fraction of administered drug excreted in urine from the time point t1 until time point t2 (fet1-t2)
Measured: up to day 9
Renal clearance of the analyte determined from the time point t1 until time point t2 (CLR,t1-t2)
Measured: up to day 9
Minimum concentration of the analyte in plasma at steady state (Cmin,ss )
Measured: up to day 9
Accumulation ratio (RA)
Measured: up to day 9
Linearity index (LI)
Measured: up to day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startFeb 2004
- Primary completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259933
- Sponsor's protocol ID
- 1207.3
- Status last verified
- Oct 2014
- First submitted
- 7 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind (at Each Dose Level), Randomised, Placebo Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of KUC 7483 CL Tablets (Dosage: 40, 120, 180 mg b.i.d.) Over 7 Days in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02259933
- Acronym / sponsor ID
- 1207.3
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- May 2004 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL after repeated dosing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KUC 7483 CL | Experimental | Drug: KUC 7483 CLincreasing repeated oral doses |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
- Age ≥21 and Age ≤60 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KUC 7483 CL | Drug | KUC 7483 CL |
| Placebo | Drug | Placebo |
Primary outcome
Number of subjects with abnormal findings in physical examination
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant changes in 12-lead ECG (electrocardiogram)
Time frame: up to 8 days after last drug administration
Number of subjects with clinically significant changes in vital signs
Time frame: up to 8 days after last drug administration
Blood Pressure, Pulse Rate, body temperature, orthostatic testing
Number of subjects with clinically significant changes in laboratory tests
Time frame: up to 8 days after last drug administration
Changes in salivary secretion
Time frame: pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7
Changes in residual urine volume
Time frame: pre-dose and 2, 4 and 8 hours after drug administration on days 1 and 7
Number of subjects with adverse events
Time frame: up to 8 days after last drug administration
Assessment of tolerability by investigator on a 5-point scale
Time frame: within 8 days after last drug administration
Number of subjects with clinically significant changes in special laboratory parameters
Time frame: up to day 8
Tropanin I, Insulin, C-Peptide, Glucagon, free fatty acids and faecal occult blood testing, Potassium, Lactate and cAMP
14 secondary outcomes
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to day 9
Time from dosing to the maximum concentration of the analyte in plasma (Tmax)
Time frame: up to day 9
Area under the concentration-time curve of the analyte in plasma (AUC)
Time frame: up to day 9
Terminal rate constant of the analyte constant in plasma (λz)
Time frame: up to day 9
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to day 9
Mean residence time of the analyte in the body after oral administration (MRTpo)
Time frame: up to day 9
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time frame: up to day 9
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: up to day 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
Fraction of administered drug excreted in urine from the time point t1 until time point t2 (fet1-t2)
Time frame: up to day 9
Renal clearance of the analyte determined from the time point t1 until time point t2 (CLR,t1-t2)
Time frame: up to day 9
Minimum concentration of the analyte in plasma at steady state (Cmin,ss )
Time frame: up to day 9
Accumulation ratio (RA)
Time frame: up to day 9
Linearity index (LI)
Time frame: up to day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KUC 7483 CL 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 7 inclusion and 15 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 9 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. Some participants in this study may receive a placebo. 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?
Number of subjects with abnormal findings in physical examination (time frame: up to 8 days after last drug administration). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2014.