HealthyPhase 1NCT02187536
Pharmacokinetics of Simvastatin and Its Metabolite Simvastatin Acid With and Without Concomitant Administration of Telmisartan in Healthy Subjects
A Phase 1 study testing Telmisartan and Simvastatin in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant administration of telmisartan Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Telmisartan and Simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Apr 2000to May 2000
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age ≥ 18 and ≤ 55 years
- Broca ≥ -20 % and ≤ +20 %
Who cannot join
- Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
- History of orthostatic hypotension, fainting spells or blackouts
Show all 24Show fewer
- Chronic or relevant acute infection
- 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) ≤ 1 month prior to administration or during the trial
- Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (30 days prior to administration or during the trial)
- Smoker
- Alcohol abuse (> 60 g/day)
- Drug abuse
- Blood donation (≤ 1 month prior to administration or during the trial)
- Excessive physical activities (≤ 5 days prior to administration or during the trial)
- Any laboratory value outside the reference range of clinical relevance
- Hypersensitivity to telmisartan and/or simvastatin and/or related classes of drugs
- For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception (e.g. sterilization, intrauterine device (IUD), oral contraceptives)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
About this study
Official title: Pharmacokinetics of Single Oral Doses of 40 mg Simvastatin and Its Metabolite Simvastatin Acid With and Without Concomitant Administration of Telmisartan 80 mg Daily, Given Orally Over 6 Days. A Randomised, Placebo Controlled, Double Blind (for Telmisartan), Two Way Cross Over Trial in Healthy Subjects
To assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant administration of telmisartan
- Conditions
- Healthy
- Being tested
- Telmisartan, Simvastatin, Telmisartan placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
SimvastatinDrug
Telmisartan placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan combined with Simvastatin | Experimental | Telmisartan once daily (day 1 to day 6) and Simvastatin given once (day 6) Receives: Drug: Telmisartan; Drug: Simvastatin |
| Simvastatin and telmisartan placebo | Active comparator | Telmisartan placebo once daily (day 1 to day 6) and Simvastatin given once (day 6) Receives: Drug: Simvastatin; Drug: Telmisartan placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of simvastatin and simvastatin acid in plasma at different time points (AUC)
Measured: Pre-dose, up to day 32 after start of treatment
Maximum concentration of simvastatin and simvastatin acid in plasma (Cmax)
Measured: Pre-dose, up to day 32 after start of treatment
Secondary outcomes (11)
Time to Cmax after a single extravascular dose (tmax)
Measured: Pre-dose, up to day 32 after start of treatment
Elimination half-life in plasma (t1/2)
Measured: Pre-dose, up to day 32 after start of treatment
Total clearance from plasma (CLtot/f)
Measured: Pre-dose, up to day 32 after start of treatment
Mean time of residence in the body (MRTtot)
Measured: Pre-dose, up to day 32 after start of treatment
Apparent volume of distribution during the terminal phase (Vz/f)
Measured: Pre-dose, up to day 32 after start of treatment
Area under the plasma concentration-time curve of telmisartan at steady state (AUCss)
Measured: Pre-dose, up to day 32 after start of treatment
Maximum concentration of telmisartan in plasma at steady state (Cmax,ss)
Measured: Pre-dose, up to day 32 after start of treatment
Number of patients with clinically relevant findings in laboratory values
Measured: Pre-dose, up to day 32 after start of treatment
Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate)
Measured: Pre-dose, up to day 32 after start of treatment
Number of patients with adverse events
Measured: Up to day 32 after start of treatment
Number of patients with clinically relevant findings in ECG
Measured: Pre-dose, up to day 32 after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startApr 2000
- Primary completionMay 2000
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
- Crossover
- Masking
- Double blind
- Enrolment
- 16 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
- NCT02187536
- Sponsor's protocol ID
- 502.341
- Status last verified
- Jul 2014
- First submitted
- 9 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Single Oral Doses of 40 mg Simvastatin and Its Metabolite Simvastatin Acid With and Without Concomitant Administration of Telmisartan 80 mg Daily, Given Orally Over 6 Days. A Randomised, Placebo Controlled, Double Blind (for Telmisartan), Two Way Cross Over Trial in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02187536
- Acronym / sponsor ID
- 502.341
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Primary completion
- May 2000 (actual)
- First posted
- 11 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 assess the pharmacokinetics of simvastatin and simvastatin acid with/without concomitant administration of telmisartan
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan combined with Simvastatin | Experimental | Drug: Telmisartan, Drug: SimvastatinTelmisartan once daily (day 1 to day 6) and Simvastatin given once (day 6) |
| Simvastatin and telmisartan placebo | Active comparator | Drug: Simvastatin, Drug: Telmisartan placeboTelmisartan placebo once daily (day 1 to day 6) and Simvastatin given once (day 6) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age ≥ 18 and ≤ 55 years
- Broca ≥ -20 % and ≤ +20 %
Key exclusion criteria (24 listed)
- Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastro-intestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Supine blood pressure at screening of systolic ≤ 110 mmHg and diastolic ≤ 60 mmHg
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 | Drug | Telmisartan combined with Simvastatin |
| Simvastatin | Drug | Simvastatin and telmisartan placebo, Telmisartan combined with Simvastatin |
| Telmisartan placebo | Drug | Simvastatin and telmisartan placebo |
Primary outcome
Area under the concentration-time curve of simvastatin and simvastatin acid in plasma at different time points (AUC)
Time frame: Pre-dose, up to day 32 after start of treatment
Maximum concentration of simvastatin and simvastatin acid in plasma (Cmax)
Time frame: Pre-dose, up to day 32 after start of treatment
11 secondary outcomes
Time to Cmax after a single extravascular dose (tmax)
Time frame: Pre-dose, up to day 32 after start of treatment
Elimination half-life in plasma (t1/2)
Time frame: Pre-dose, up to day 32 after start of treatment
Total clearance from plasma (CLtot/f)
Time frame: Pre-dose, up to day 32 after start of treatment
Mean time of residence in the body (MRTtot)
Time frame: Pre-dose, up to day 32 after start of treatment
Apparent volume of distribution during the terminal phase (Vz/f)
Time frame: Pre-dose, up to day 32 after start of treatment
Area under the plasma concentration-time curve of telmisartan at steady state (AUCss)
Time frame: Pre-dose, up to day 32 after start of treatment
Maximum concentration of telmisartan in plasma at steady state (Cmax,ss)
Time frame: Pre-dose, up to day 32 after start of treatment
Number of patients with clinically relevant findings in laboratory values
Time frame: Pre-dose, up to day 32 after start of treatment
Number of patients with clinically relevant findings in vital signs (blood pressure, pulse rate)
Time frame: Pre-dose, up to day 32 after start of treatment
Number of patients with adverse events
Time frame: Up to day 32 after start of treatment
Number of patients with clinically relevant findings in ECG
Time frame: Pre-dose, up to day 32 after start of treatment
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 11 Jul 2014.
- Related InfoLink provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 and Simvastatin 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 24 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 11 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?
Area under the concentration-time curve of simvastatin and simvastatin acid in plasma at different time points (AUC) (time frame: Pre-dose, up to day 32 after start of treatment). The study lists 2 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 11 Jul 2014.