HealthyPhase 1NCT02259764
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of KUC 7483 CL Tablets in Healthy Male Volunteers
A Phase 1 study testing KUC 7483 CL - single rising dose and standardized high fat meal in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- KUC 7483 CL - single rising dose and standardized high fat meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Sep 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 30 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
- 1.1 No finding deviating from normal and of clinical relevance
- 1.2 No evidence of a clinically relevant concomitant disease
- Age ≥ 30 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 (GCP) 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 16Show 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
- The clinical relevance of study parameters will be assessed by the investigator or his deputy
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (400, 440 and 480 mg) of KUC 7483 CL Tablets in Healthy Male Volunteers. A Double-blind at Each Dose Level, Randomised, Placebo Controlled Study
Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL
- Conditions
- Healthy
- Being tested
- KUC 7483 CL - single rising dose, Placebo, standardized high fat meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KUC 7483 CL - single rising doseDrug
PlaceboDrug
standardized high fat mealOther
| Study group | Role | What they receive |
|---|---|---|
| KUC 7483 CL - single rising dose | Experimental | Treatment 1: KUC 7483 CL - low dose
Treatment 2: KUC 7483 CL - medium dose
Treatment 3: KUC 7483 CL - high dose
In treatment 3 the same subjects as in treatment 2 received drug immediately after the ingestion of a standardized high fat meal Receives: Drug: KUC 7483 CL - single rising dose; Other: standardized high fat meal |
| 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 abnormal changes in laboratory parameters
special parameters, Tropanin I, insulin, C-Peptide, glucagon, free fatty acids, lactate, potassium, cAMP and faecal occult blood testing
Measured: up to 8 days after last drug administration
Number of subjects with clinically significant changes in vital signs
Blood Pressure, Pulse Rate, Respiratory Rate, body temperature, orthostatic testing
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 adverse events
Measured: up to 8 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Measured: 8 days after last drug administration
Secondary outcomes (12)
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 48 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: up to 48 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 48 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Measured: up to 48 hours after drug administration
λ z (terminal rate constant of the analyte in plasma)
Measured: up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Measured: up to 48 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: up to 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: up to 48 hours after drug administration
Aet1-t2 (amount of the analyte that is eliminated in urine from the time point t1 until time point t2)
Measured: up to 48 hours after drug administration
fet1-t2 (fraction of administered drug excreted unchanged in urine from the time point t1 until time point t2)
Measured: up to 48 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte determined from the time point t1 until time point t2)
Measured: up to 48 hours after drug administration
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 startAug 2004
- Primary completionSep 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
- 24 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
- NCT02259764
- Sponsor's protocol ID
- 1207.6
- Status last verified
- Oct 2014
- First submitted
- 6 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
- Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (400, 440 and 480 mg) of KUC 7483 CL Tablets in Healthy Male Volunteers. A Double-blind at Each Dose Level, Randomised, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02259764
- Acronym / sponsor ID
- 1207.6
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Sep 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KUC 7483 CL - single rising dose | Experimental | Drug: KUC 7483 CL - single rising dose, Other: standardized high fat mealTreatment 1: KUC 7483 CL - low dose Treatment 2: KUC 7483 CL - medium dose Treatment 3: KUC 7483 CL - high dose In treatment 3 the same subjects as in treatment 2 received drug immediately after the ingestion of a standardized high fat meal |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 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
- 1.1 No finding deviating from normal and of clinical relevance
- 1.2 No evidence of a clinically relevant concomitant disease
- Age ≥ 30 and Age ≤ 60 years
Key exclusion criteria (16 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 - single rising dose | Drug | KUC 7483 CL - single rising dose |
| Placebo | Drug | Placebo |
| standardized high fat meal | Other | KUC 7483 CL - single rising dose |
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 abnormal changes in laboratory parameters
Time frame: up to 8 days after last drug administration
special parameters, Tropanin I, insulin, C-Peptide, glucagon, free fatty acids, lactate, potassium, cAMP and faecal occult blood testing
Number of subjects with clinically significant changes in vital signs
Time frame: up to 8 days after last drug administration
Blood Pressure, Pulse Rate, Respiratory Rate, body temperature, orthostatic testing
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 adverse events
Time frame: up to 8 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
Time frame: 8 days after last drug administration
12 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 48 hours after drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 48 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: up to 48 hours after drug administration
λ z (terminal rate constant of the analyte in plasma)
Time frame: up to 48 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 48 hours after drug administration
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 48 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 48 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 48 hours after drug administration
Aet1-t2 (amount of the analyte that is eliminated in urine from the time point t1 until time point t2)
Time frame: up to 48 hours after drug administration
fet1-t2 (fraction of administered drug excreted unchanged in urine from the time point t1 until time point t2)
Time frame: up to 48 hours after drug administration
CLR,t1-t2 (renal clearance of the analyte determined from the time point t1 until time point t2)
Time frame: up to 48 hours after drug administration
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 - single rising dose and standardized high fat meal 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 16 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 6 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.