HealthyPhase 1NCT02264028
Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers
A Phase 1 study testing [14C]-DK-AH 269 CL, solution for infusion and [14C]-DK-AH 269 CL, drinking solution in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate absorption, metabolism and excretion of [14C]-DK-AH 269 CL after oral and intravenous administration in healthy volunteers To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous administration to healthy volunteers Read more about this study
- Who is it for?
- Ages 50 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]-DK-AH 269 CL, solution for infusion and [14C]-DK-AH 269 CL, drinking solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Apr 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 50 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 to 65 years of age
- Body Mass Index (BMI) of 19.9 to 29.9 kg/m2
- Resting heart rate (HR) (after 5 min. in the supine position) of more than 55 bpm
- All volunteers will have given their written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
Who cannot join
- Any finding at the medical examination (including BP, HR and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, hematological/oncological, immunological or hormonal disorders
- Diseases of the central nervous system 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
Show all 22Show fewer
- Intake of drugs with a long half-life (> 24 hours) within ten half-lives of the respective drug before enrolment in the study
- Use of any drugs which might influence the results of the trial within two weeks prior to administration or during the trial
- Participation in another trial with an investigational drug (≤ 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 2 months prior to administration or during the trial)
- Excessive physical activities (within the last week before the study)
- Any laboratory value outside the reference range and of clinical relevance
- Inability to comply with dietary regimen of study centre
- Not necessarily clinically relevant abnormalities, but specific exclusion criteria for the drugs under study or for the study:
- Subjects at increased risk for development of cardiac arrhythmia (e.g. family history of long QT syndrome or sudden cardiac death)
- ECG: PR interval > 210 ms
- HR at rest ≤ 55 beats per minute (bpm)
- Relevant ophthalmological disease
About this study
Official title: Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL After Administration of Single Doses of 5 mg [14C]-DK-AH 269 CL Intravenously and 10 mg [14C]-DK-AH 269 CL as Oral Solution in a Parallel-group Design in 12 Healthy Male Volunteers
- To investigate absorption, metabolism and excretion of [14C]-DK-AH 269 CL after oral and intravenous administration in healthy volunteers
- To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous administration to healthy volunteers
- Conditions
- Healthy
- Being tested
- [14C]-DK-AH 269 CL, solution for infusion, [14C]-DK-AH 269 CL, drinking solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-DK-AH 269 CL, solution for infusionDrug
[14C]-DK-AH 269 CL, drinking solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| [14C]-DK-AH 269 CL intravenous | Active comparator | Not described Receives: Drug: [14C]-DK-AH 269 CL, solution for infusion |
| [14C]-DK-AH 269 CL oral | Experimental | Not described Receives: Drug: [14C]-DK-AH 269 CL, drinking solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum measured concentration of the analytes in plasma (Cmax)
Measured: Up to 96 hours after start of treatment
Area under the concentration-time curve of the analytes in plasma (AUC)
Measured: Up to 96 hours after start of treatment
Time from dosing to the maximum concentration of the analytes in plasma (tmax)
Measured: Up to 96 hours after start of treatment
Terminal rate constant of the analytes in plasma (λz)
Measured: Up to 96 hours after start of treatment
Terminal half-life of the analytes in plasma (t1/2)
Measured: Up to 96 hours after start of treatment
Mean residence time of the analytes in the body after intravenous administration (MRT)
Measured: Up to 96 hours after start of treatment
Mean residence time of the analytes in the body after oral administration (MRTpo)
Measured: Up to 96 hours after start of treatment
Apparent clearance of the analytes in plasma following extravascular administration (CL/F)
Measured: Up to 96 hours after start of treatment
Total clearance of the analytes in plasma following intravascular administration (CL)
Measured: Up to 96 hours after start of treatment
Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F)
Measured: Up to 96 hours after start of treatment
Volume of distribution at steady state (Vss)
Measured: Up to 96 hours after start of treatment
Fraction of analytes eliminated in urine from 0 to the time of the last quantifiable data point (fe0-tz)
Measured: Up to 120 hours after start of treatment
Fraction of analytes eliminated in faeces from 0 to the time of the last quantifiable data point (fefaeces,0-tz)
Measured: Up to 120 hours after start of treatment
Renal clearance of the analytes from 0 to the time of the last quantifiable data point (CLR,0-tz)
Measured: Up to 120 hours after start of treatment
Fraction of dose absorbed, based on radioactivity data (Fa)
Measured: Up to 96 hours after start of treatment
Absolute bioavailability of the analytes after oral administration (F)
Measured: Up to 96 hours after start of treatment
Ratio of CBlood cells/Cplasma [14C]-radioactivity
Measured: Up to 96 hours after start of treatment
Number of patients with clinically significant findings in vital signs
blood pressure, heart rate
Measured: up to 12 days after last drug administration
Number of patients with clinically significant findings in 12-lead ECG
Measured: up to 12 days after last drug administration
Number of patients with clinically significant findings in 2-lead ECG (telemetry)
Measured: up to 90 minutes after start of treatment
Clinically significant changes from baseline in physical examination
Measured: Pre-dose, and 12 days after last drug administration
Occurrence of visual phenomena
questionnaire
Measured: up to 120 hours after start of treatment
Number of patients with clinically significant findings in clinical laboratory tests
Measured: up to 12 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startMar 2004
- Primary completionApr 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
- None (open label)
- Enrolment
- 12 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
- NCT02264028
- Sponsor's protocol ID
- 503.209
- Status last verified
- Oct 2014
- First submitted
- 13 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL After Administration of Single Doses of 5 mg [14C]-DK-AH 269 CL Intravenously and 10 mg [14C]-DK-AH 269 CL as Oral Solution in a Parallel-group Design in 12 Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02264028
- Acronym / sponsor ID
- 503.209
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Apr 2004 (actual)
- First posted
- 15 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.
- To investigate absorption, metabolism and excretion of [14C]-DK-AH 269 CL after oral and intravenous administration in healthy volunteers
- To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous administration to healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [14C]-DK-AH 269 CL intravenous | Active comparator | Drug: [14C]-DK-AH 269 CL, solution for infusion |
| [14C]-DK-AH 269 CL oral | Experimental | Drug: [14C]-DK-AH 269 CL, drinking solution |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 to 65 years of age
- Body Mass Index (BMI) of 19.9 to 29.9 kg/m2
- Resting heart rate (HR) (after 5 min. in the supine position) of more than 55 bpm
- All volunteers will have given their written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
Key exclusion criteria (22 listed)
- Any finding at the medical examination (including BP, HR and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, hematological/oncological, immunological or hormonal disorders
- Diseases of the central nervous system or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
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 |
|---|---|---|
| [14C]-DK-AH 269 CL, solution for infusion | Drug | [14C]-DK-AH 269 CL intravenous |
| [14C]-DK-AH 269 CL, drinking solution | Drug | [14C]-DK-AH 269 CL oral |
Primary outcome
Maximum measured concentration of the analytes in plasma (Cmax)
Time frame: Up to 96 hours after start of treatment
Area under the concentration-time curve of the analytes in plasma (AUC)
Time frame: Up to 96 hours after start of treatment
Time from dosing to the maximum concentration of the analytes in plasma (tmax)
Time frame: Up to 96 hours after start of treatment
Terminal rate constant of the analytes in plasma (λz)
Time frame: Up to 96 hours after start of treatment
Terminal half-life of the analytes in plasma (t1/2)
Time frame: Up to 96 hours after start of treatment
Mean residence time of the analytes in the body after intravenous administration (MRT)
Time frame: Up to 96 hours after start of treatment
Mean residence time of the analytes in the body after oral administration (MRTpo)
Time frame: Up to 96 hours after start of treatment
Apparent clearance of the analytes in plasma following extravascular administration (CL/F)
Time frame: Up to 96 hours after start of treatment
Total clearance of the analytes in plasma following intravascular administration (CL)
Time frame: Up to 96 hours after start of treatment
Apparent volume of distribution of the analytes during the terminal phase λz following extravascular administration (Vz/F)
Time frame: Up to 96 hours after start of treatment
Volume of distribution at steady state (Vss)
Time frame: Up to 96 hours after start of treatment
Fraction of analytes eliminated in urine from 0 to the time of the last quantifiable data point (fe0-tz)
Time frame: Up to 120 hours after start of treatment
Fraction of analytes eliminated in faeces from 0 to the time of the last quantifiable data point (fefaeces,0-tz)
Time frame: Up to 120 hours after start of treatment
Renal clearance of the analytes from 0 to the time of the last quantifiable data point (CLR,0-tz)
Time frame: Up to 120 hours after start of treatment
Fraction of dose absorbed, based on radioactivity data (Fa)
Time frame: Up to 96 hours after start of treatment
Absolute bioavailability of the analytes after oral administration (F)
Time frame: Up to 96 hours after start of treatment
Ratio of CBlood cells/Cplasma [14C]-radioactivity
Time frame: Up to 96 hours after start of treatment
Number of patients with clinically significant findings in vital signs
Time frame: up to 12 days after last drug administration
blood pressure, heart rate
Number of patients with clinically significant findings in 12-lead ECG
Time frame: up to 12 days after last drug administration
Number of patients with clinically significant findings in 2-lead ECG (telemetry)
Time frame: up to 90 minutes after start of treatment
Clinically significant changes from baseline in physical examination
Time frame: Pre-dose, and 12 days after last drug administration
Occurrence of visual phenomena
Time frame: up to 120 hours after start of treatment
questionnaire
Number of patients with clinically significant findings in clinical laboratory tests
Time frame: up to 12 days after last 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 15 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 [14C]-DK-AH 269 CL, solution for infusion and [14C]-DK-AH 269 CL, drinking solution 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 4 inclusion and 22 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?
Maximum measured concentration of the analytes in plasma (Cmax) (time frame: Up to 96 hours after start of treatment). The study lists 23 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 15 Oct 2014.