HealthyPhase 1NCT02262780
Safety, Tolerability and Pharmacokinetics of Single Rising and Multiple Oral Doses of Telmisartan / Hydrochlorothiazide (HCTZ) in Healthy Male Volunteers
A Phase 1 study testing Low dose of telmisartan, High dose of telmisartan and HCTZ in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Group 1: To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and T80/H12.5) Group 2: To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7 days) 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?
- Low dose of telmisartan, High dose of telmisartan and HCTZ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2003to 15 Feb 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males 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 (BP), pulse rate (PR), body temperature), 12-lead ECG, clinical laboratory tests
- Age ≥20 and Age ≤35 years
- Body Mass Index (BMI) ≥17.6 and BMI ≤26.4 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with "Good Clinical Practice (GCP)"
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 laboratory value outside the reference range that is of clinical relevance
- Positive result for hepatitis B surface (HBs) antigen, anti hepatitis C virus (HCV) antibodies, Syphilitic test or HIV test
- Surgery of gastrointestinal tract (except appendectomy)
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- History of relevant orthostatic hypotension (mean standing SBP varies by ≥ 20 mmHg from mean supine systolic blood pressure (SBP) and/or mean standing diastolic blood pressure (DBP) varies 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; known hypersensitivity to any other angiotensin II receptor antagonist; known hypersensitivity to sulfonamides or sulphonamide-derived drugs (e.g. thiazides)
- History of impaired glucose tolerance
- History of hypokalemia
- History of hyperuricemia
- Salt restriction therapy
- 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
- 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 prior to administration or during the trial
- Participation in another trial with an investigational drug within four months or 6 half-lives of the investigational drug, whichever is longer, prior to administration or during the trial
- Smoker (more than 20 cigarettes /day)
- Alcohol abuse
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within seven days prior to administration)
- Intake of alcohol within two days prior to administration
- Inability to comply with dietary regimen of study centre
- Inability to comply with smoking cessation during hospitalization
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (40 mg Telmisartan / 12.5 mg HCTZ to 80 mg Telmisartan / 12.5 mg HCTZ) and Multiple Oral Doses (80 mg Telmisartan / 12.5 mg HCTZ) of Drug in Healthy Male Volunteers
Group 1:
To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and T80/H12.5)
Group 2:
To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7 days)
- Conditions
- Healthy
- Being tested
- Low dose of telmisartan, High dose of telmisartan, HCTZ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of telmisartanDrug
High dose of telmisartanDrug
HCTZDrug
| Study group | Role | What they receive |
|---|---|---|
| Single low dose Telmisartan with HCTZ | Experimental | Not described Receives: Drug: Low dose of telmisartan; Drug: HCTZ |
| Single high dose Telmisartan with HCTZ | Experimental | Not described Receives: Drug: High dose of telmisartan; Drug: HCTZ |
| Multiple high dose Telmisartan with HCTZ | Experimental | Not described Receives: Drug: High dose of telmisartan; Drug: HCTZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with clinically relevant findings in physical examination
Measured: up to 10 days after last drug administration
Number of patients with clinically relevant findings in vital signs
blood pressure, pulse rate, body temperature
Measured: up to 10 days after last drug administration
Number of patients with clinically relevant findings in 12-lead ECG
Measured: up to 10 days after last drug administration
Number of patients with clinically relevant findings in clinical laboratory tests
Measured: up to 10 days after last drug administration
Number of patients with adverse events
Measured: up to 10 days after last drug administration
Global assessment of tolerability by the investigator
verbal rating scale
Measured: up to 10 days after last drug administration
Secondary outcomes (14)
Maximum concentration of the analytes in plasma (Cmax)
Measured: Up to 96 hours after drug administration
Area under the concentration time curve of the analytes in plasma (AUC)
Measured: Up to 96 hours after drug administration
Time from dosing to maximum concentration of the analytes in plasma (tmax)
Measured: Up to 96 hours after drug administration
Terminal rate constant of the analytes in plasma (λz)
Measured: Up to 96 hours after drug administration
Terminal half-life of the analytes in plasma (t1/2)
Measured: Up to 96 hours after drug administration
Mean residence time of the analytes in the body after po administration (MRTpo)
Measured: Up to 96 hours after drug administration
Apparent clearance of the analytes in the plasma after extravascular administration (CL/F)
Measured: Up to 96 hours after drug administration
Apparent volume of distribution of the analytes in plasma during the terminal phase λz following an extravascular dose (Vz/F)
Measured: Up to 96 hours after drug administration
Amount of HCTZ that is eliminated in urine from the time interval t1 to t2 (Aet1-t2)
Measured: Up to 48 hours after drug administration
Fraction of HCTZ excreted unchanged in urine from time point t1 to t2 (fet1-t2)
Measured: Up to 48 hours after drug administration
Renal clearance of HCTZ in plasma from the time point t1 until the time point t2 (CLR, t1-t2)
Measured: Up to 48 hours after drug administration
Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: Up to 96 hours after drug administration
Average concentration of the analytes in plasma at steady state (Cavg)
Measured: Up to 96 hours after drug administration
Accumulation ratio of the analytes in plasma after multiple dose administration over a uniform dosing interval τ (RA)
Measured: Up to 96 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 posted13 Oct 2014 (estimated)
- Study start1 Dec 2003
- Primary completion15 Feb 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
- 20 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
- NCT02262780
- Sponsor's protocol ID
- 502.453
- Status last verified
- Nov 2023
- First submitted
- 10 Oct 2014
- Last updated
- 8 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (40 mg Telmisartan / 12.5 mg HCTZ to 80 mg Telmisartan / 12.5 mg HCTZ) and Multiple Oral Doses (80 mg Telmisartan / 12.5 mg HCTZ) of Drug in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02262780
- Acronym / sponsor ID
- 502.453
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2003 (actual)
- Primary completion
- 15 Feb 2004 (actual)
- First posted
- 13 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.
Group 1:
To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and T80/H12.5)
Group 2:
To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single low dose Telmisartan with HCTZ | Experimental | Drug: Low dose of telmisartan, Drug: HCTZ |
| Single high dose Telmisartan with HCTZ | Experimental | Drug: High dose of telmisartan, Drug: HCTZ |
| Multiple high dose Telmisartan with HCTZ | Experimental | Drug: High dose of telmisartan, Drug: HCTZ |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males 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 (BP), pulse rate (PR), body temperature), 12-lead ECG, clinical laboratory tests
- Age ≥20 and Age ≤35 years
- Body Mass Index (BMI) ≥17.6 and BMI ≤26.4 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with "Good Clinical Practice (GCP)"
Key exclusion criteria (28 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 laboratory value outside the reference range that is of clinical relevance
- Positive result for hepatitis B surface (HBs) antigen, anti hepatitis C virus (HCV) antibodies, Syphilitic test or 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 |
|---|---|---|
| Low dose of telmisartan | Drug | Single low dose Telmisartan with HCTZ |
| High dose of telmisartan | Drug | Multiple high dose Telmisartan with HCTZ, Single high dose Telmisartan with HCTZ |
| HCTZ | Drug | Multiple high dose Telmisartan with HCTZ, Single high dose Telmisartan with HCTZ, Single low dose Telmisartan with HCTZ |
Primary outcome
Number of patients with clinically relevant findings in physical examination
Time frame: up to 10 days after last drug administration
Number of patients with clinically relevant findings in vital signs
Time frame: up to 10 days after last drug administration
blood pressure, pulse rate, body temperature
Number of patients with clinically relevant findings in 12-lead ECG
Time frame: up to 10 days after last drug administration
Number of patients with clinically relevant findings in clinical laboratory tests
Time frame: up to 10 days after last drug administration
Number of patients with adverse events
Time frame: up to 10 days after last drug administration
Global assessment of tolerability by the investigator
Time frame: up to 10 days after last drug administration
verbal rating scale
14 secondary outcomes
Maximum concentration of the analytes in plasma (Cmax)
Time frame: Up to 96 hours after drug administration
Area under the concentration time curve of the analytes in plasma (AUC)
Time frame: Up to 96 hours after drug administration
Time from dosing to maximum concentration of the analytes in plasma (tmax)
Time frame: Up to 96 hours after drug administration
Terminal rate constant of the analytes in plasma (λz)
Time frame: Up to 96 hours after drug administration
Terminal half-life of the analytes in plasma (t1/2)
Time frame: Up to 96 hours after drug administration
Mean residence time of the analytes in the body after po administration (MRTpo)
Time frame: Up to 96 hours after drug administration
Apparent clearance of the analytes in the plasma after extravascular administration (CL/F)
Time frame: Up to 96 hours after drug administration
Apparent volume of distribution of the analytes in plasma during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: Up to 96 hours after drug administration
Amount of HCTZ that is eliminated in urine from the time interval t1 to t2 (Aet1-t2)
Time frame: Up to 48 hours after drug administration
Fraction of HCTZ excreted unchanged in urine from time point t1 to t2 (fet1-t2)
Time frame: Up to 48 hours after drug administration
Renal clearance of HCTZ in plasma from the time point t1 until the time point t2 (CLR, t1-t2)
Time frame: Up to 48 hours after drug administration
Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: Up to 96 hours after drug administration
Average concentration of the analytes in plasma at steady state (Cavg)
Time frame: Up to 96 hours after drug administration
Accumulation ratio of the analytes in plasma after multiple dose administration over a uniform dosing interval τ (RA)
Time frame: Up to 96 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 8 Dec 2023.
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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 Low dose of telmisartan, High dose of telmisartan and HCTZ 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 28 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 8 Dec 2023. 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 relevant findings in physical examination (time frame: up to 10 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 8 Dec 2023.