HealthyPhase 1NCT02194309
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine in Healthy Male Volunteers
A Phase 1 study testing Telmisartan low, Telmisartan high and amlodipine in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg… Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telmisartan low, Telmisartan high and amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Dec 2006
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers according to the following criteria:
- No finding deviating of clinical relevance and no evidence of a clinically relevant concomitant disease based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests
- Age ≥20 and Age ≤35 years
- Body weight ≥50 kg
- Body mass index (BMI) ≥17.6 and BMI ≤26.4 kg/m2
- Signed and dated written informed consent before admission to the trial
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
- Chronic or relevant acute infections
- Any clinical relevant findings of the laboratory test deviating from normal
- Positive result for either hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
- History of surgery of gastrointestinal tract (except appendectomy)
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- History of relevant orthostatic hypotension (mean standing systolic blood pressure (SBP) varied by ≥20 mmHg from mean supine SBP or mean standing diastolic blood pressure (DBP) varied by ≥10 mmHg from mean supine DBP), fainting spells or blackouts
- History of hepatic dysfunction (e.g., biliary cirrhosis, cholestasis)
- History of serious renal dysfunction
- History of bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
- History of cerebrovascular disorder
- History of hyperkalemia
- Known hypersensitivity to any component of the formulation, or to any other Angiotensin Receptor Blocker (ARB), angiotensin converting enzyme or dihydropyridine
- 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 before administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 7 days before administration or during the trial
- Participation in another trial with an investigational drug within 4 months or 6 half-lives of the investigational drug before administration
- Smoker (≥20 cigarettes/day)
- Alcohol abuse (60 g or more ethanol/day: ex. 3 middle-sized bottles of beer, 3 gous (equivalent to 540 mL) of sake)
- Drug abuse
- Blood donation (more than 100 mL within 4 weeks before administration or during the trial)
- Excessive physical activities (within 1 week before administration or during the trial)
- Intake of alcohol within 2 days before administration
- Inability to comply with dietary regimen of trial centre
- Intake of any drugs/supplements with ingredient of hypericum perforatum (citrus fruits, Sevilla orange) within 5 days prior to administration
- Inability to refrain from smoking on trial days
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine (Free Dose Combination) in Healthy Male Volunteers
To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine once daily for 10 days
- Conditions
- Healthy
- Being tested
- Telmisartan low, Telmisartan high, amlodipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan lowDrug
Telmisartan highDrug
amlodipineDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan low + amlodipine | Experimental | Not described Receives: Drug: Telmisartan low; Drug: amlodipine |
| Telmisartan high + amlodipine | Experimental | Not described Receives: Drug: Telmisartan high; Drug: amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate, body temperature)
Measured: up to 6 days after last administration in multiple dose phase
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Measured: up to 6 days after last administration in multiple dose phase
Number of patients with clinically significant changes in laboratory parameters
Measured: up to 6 days after last administration in multiple dose phase
Number of patients with adverse events
Measured: up to 6 days after last administration in multiple dose phase
Assessment of tolerability by investigator on a four-point scale
Measured: up to 6 days after last administration in multiple dose phase
Secondary outcomes (13)
Cmax (maximum measured concentration of the analyte in plasma) for several time points
Measured: up to day 16
tmax (time from dosing to the maximum measured concentration of the analyte in plasma) for several time points
Measured: up to day 16
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: up to day 16
AUC (area under the concentration-time curve of the analyte in plasma) for several time points
Measured: up to day 16
λz (terminal rate constant in plasma) for several time points
Measured: up to day 16
t1/2 (terminal half-life of the analyte in plasma) for several time points
Measured: up to day 16
MRTpo (mean residence time of the analyte in the body after oral administration) for several time points
Measured: up to day 16
CL/F (apparent clearance of the analyte in plasma following extravascular administration) for several time points
Measured: up to day 16
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration) for several time points
Measured: up to day 16
Accumulation ratio (RA) based on Cmax
Measured: up to day 16
RA based on AUC
Measured: up to day 16
Predose concentration (Cpre) for several time points
Measured: up to day 10
C24,10
Measured: 24 hours after last administration on day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startSep 2006
- Primary completionDec 2006
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
- NCT02194309
- Sponsor's protocol ID
- 1235.9
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine (Free Dose Combination) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02194309
- Acronym / sponsor ID
- 1235.9
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2006 (actual)
- First posted
- 18 Jul 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 safety, tolerability, and pharmacokinetics of telmisartan and amlodipine following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine once daily for 10 days
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan low + amlodipine | Experimental | Drug: Telmisartan low, Drug: amlodipine |
| Telmisartan high + amlodipine | Experimental | Drug: Telmisartan high, Drug: amlodipine |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- No finding deviating of clinical relevance and no evidence of a clinically relevant concomitant disease based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, body temperature), 12-lead ECG, clinical laboratory tests
- Age ≥20 and Age ≤35 years
- Body weight ≥50 kg
- Body mass index (BMI) ≥17.6 and BMI ≤26.4 kg/m2
- Signed and dated written informed consent before admission to the trial
Key exclusion criteria (25 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
- Chronic or relevant acute infections
- Any clinical relevant findings of the laboratory test deviating from normal
- Positive result for either hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies, syphilitic test or human immunodeficiency virus (HIV) test
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 |
|---|---|---|
| Telmisartan low | Drug | Telmisartan low + amlodipine |
| Telmisartan high | Drug | Telmisartan high + amlodipine |
| amlodipine | Drug | Telmisartan high + amlodipine, Telmisartan low + amlodipine |
Primary outcome
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate, body temperature)
Time frame: up to 6 days after last administration in multiple dose phase
Number of patients with clinically significant changes in 12-lead electrocardiogram (ECG)
Time frame: up to 6 days after last administration in multiple dose phase
Number of patients with clinically significant changes in laboratory parameters
Time frame: up to 6 days after last administration in multiple dose phase
Number of patients with adverse events
Time frame: up to 6 days after last administration in multiple dose phase
Assessment of tolerability by investigator on a four-point scale
Time frame: up to 6 days after last administration in multiple dose phase
13 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma) for several time points
Time frame: up to day 16
tmax (time from dosing to the maximum measured concentration of the analyte in plasma) for several time points
Time frame: up to day 16
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to day 16
AUC (area under the concentration-time curve of the analyte in plasma) for several time points
Time frame: up to day 16
λz (terminal rate constant in plasma) for several time points
Time frame: up to day 16
t1/2 (terminal half-life of the analyte in plasma) for several time points
Time frame: up to day 16
MRTpo (mean residence time of the analyte in the body after oral administration) for several time points
Time frame: up to day 16
CL/F (apparent clearance of the analyte in plasma following extravascular administration) for several time points
Time frame: up to day 16
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration) for several time points
Time frame: up to day 16
Accumulation ratio (RA) based on Cmax
Time frame: up to day 16
RA based on AUC
Time frame: up to day 16
Predose concentration (Cpre) for several time points
Time frame: up to day 10
C24,10
Time frame: 24 hours after last administration on day 10
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 18 Jul 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 Telmisartan low, Telmisartan high and amlodipine 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 6 inclusion and 25 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 18 Jul 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?
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate, body temperature) (time frame: up to 6 days after last administration in multiple dose phase). The study lists 5 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 18 Jul 2014.