HealthyPhase 1NCT02171039
Relative Bioavailability of Dabigatran and Atorvastatin in Healthy Male and Female Volunteers
A Phase 1 study testing Dabigatran and Atorvastatin in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate the bioavailability of dabigatran with and without concomitant administration of atorvastatin and the bioavailability of atorvastatin with and without concomitant administration of dabigatran etexilate Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dabigatran and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Aug 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females 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
- Age ≥18 and ≤65 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Liver transaminases (ALT; aspartate aminotransferase (AST); GGT) and creatin kinase (CK) are to be within the normal range
- Haemoglobin values within the normal range
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Who cannot join
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Relevant surgery of gastrointestinal tract
- History of any bleeding disorder or acute blood coagulation defect
- History or presence of acute liver disease
- History or presence of myopathy
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
Show all 25Show fewer
- 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
- 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
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Within 5 days of study medication no intake of grapefruit, grapefruit juice, or products containing grapefruit juice, Seville oranges, garlic supplements, or St. John's Wort
- Blood donation (more than 100 mL within four weeks prior to administration o during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- Females of child bearing potential who are pregnant, breast feeding or who are either not surgically sterile or are sexually active and not using an acceptable form of contraception as either the oral contraceptives since at least two months or the double barrier method, i.e. intrauterine device with spermicide and condom for the male partner
- Male subjects will not agree to minimise the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the post study medical. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)
- Planned surgeries within four weeks following the end-of study examination
- Intake of medication, which influences the blood clotting, i.e., acetylsalicylic acid, cumarin etc.
- The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- Vulnerable subjects (e.g. persons kept in detention).
About this study
Official title: Relative Bioavailability of Dabigatran and Atorvastatin After 150 mg BID Dabigatran Etexilate and Atorvastatin at 80 mg QD Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers (an Open-label, Randomised, Multiple-dose, Three-way Crossover Study)
To investigate the bioavailability of dabigatran with and without concomitant administration of atorvastatin and the bioavailability of atorvastatin with and without concomitant administration of dabigatran etexilate
- Conditions
- Healthy
- Being tested
- Dabigatran, Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
AtorvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| dabigatran plus atorvastatin | Experimental | Not described Receives: Drug: Dabigatran; Drug: Atorvastatin |
| dabigatran | Active comparator | Not described Receives: Drug: Dabigatran |
| atorvastatin | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of the analyte in plasma at steady state over one dosing interval ( AUCτ,ss)
Measured: Day 4
Maximum concentration of the analyte in plasma at steady state (Cmax,ss)
Measured: 2 hours before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after drug administration on day 4
Secondary outcomes (23)
Area under the concentration-time curve of the analyte in plasma from the time point 0 after the last dose at steady state to the last quantifiable analyte plasma concentration within the uniform dosing interval τ (AUC0-tz,ss)
Measured: Up to day 7 after administration
Time of last measurable concentration of the analyte in plasma within the dosing interval τ at steady state (tz,ss)
Measured: Up to day 7 after administration
Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Measured: Up to day 7 after administration
Apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration (CL/Fss)
Measured: Up to day 7 after administration
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: 2 hours before and 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after drug administration
Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmin,ss )
Measured: Up to day 7 after administration
Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Measured: 2 hours before drug administration on day 1, 2, 3 and 4
Mean residence time of the analyte in the body at steady state after p.o. administration (MRTp.o.,ss)
Measured: Up to day 7 after administration
Apparent volume of distribution during the terminal phase λz at steady state following an extravascular administration (Vz/Fss)
Measured: Up to day 7 after administration
Amount of analyte that was eliminated in urine at steady state over an uniform dosing interval τ (Aeτ,ss)
Measured: Day 4 and 5 after administration
Fraction of parent drug eliminated in urine at steady state over a uniform dosing interval τ (feτ,ss)
Measured: Day 4 and 5 after administration
Renal clearance of the analyte at steady state determined over the dosing interval τ (CLR,ss)
Measured: Day 4 and 5 after administration
Maximum effect ratio at steady state (ERmax_ss) for activated thrombin time (aPTT) and ecarin clotting time (ECT)
Measured: Up to day 7 after administration
Area under the effect curve (baseline corrected) (AUECτ,ss) for aPTT and ECT
Measured: Day 4 and 5
Change from baseline in blood pressure and puls rate (BP, PR)
Measured: Baseline, day 78
Change from baseline in physical examination
Measured: Baseline, day 78
Change from baseline in 12-lead electrocardiogram
Measured: Baseline, day 78
Change from baseline in clinical laboratory tests
Measured: Baseline, day 78
Number of Participants with Serious and Non-Serious Adverse Events
Measured: Up to day 78
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Measured: Day 78
Ecarin clotting time (ECT) prolongation at trough (ER(pre,ss))
Measured: Up to day 7 after administration
Amount of total active HMG-CoA reductase inhibitors in plasma
Measured: Up to day 7 after administration
Activated partial thromboplastin time (aPTT) prolongation at trough (ER(pre,ss))
Measured: Up to day 7 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2006
- Primary completionAug 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
- Randomised
- Intervention model
- Crossover
- 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
- NCT02171039
- Sponsor's protocol ID
- 1160.58
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Dabigatran and Atorvastatin After 150 mg BID Dabigatran Etexilate and Atorvastatin at 80 mg QD Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers (an Open-label, Randomised, Multiple-dose, Three-way Crossover Study)
- ClinicalTrials.gov ID
- NCT02171039
- Acronym / sponsor ID
- 1160.58
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Aug 2006 (actual)
- First posted
- 23 Jun 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 the bioavailability of dabigatran with and without concomitant administration of atorvastatin and the bioavailability of atorvastatin with and without concomitant administration of dabigatran etexilate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dabigatran plus atorvastatin | Experimental | Drug: Dabigatran, Drug: Atorvastatin |
| dabigatran | Active comparator | Drug: Dabigatran |
| atorvastatin | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy males and females 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
- Age ≥18 and ≤65 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- Liver transaminases (ALT; aspartate aminotransferase (AST); GGT) and creatin kinase (CK) are to be within the normal range
Key exclusion criteria (25 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Relevant surgery of gastrointestinal tract
- History of any bleeding disorder or acute blood coagulation defect
- History or presence of acute liver disease
- History or presence of myopathy
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 |
|---|---|---|
| Dabigatran | Drug | dabigatran, dabigatran plus atorvastatin |
| Atorvastatin | Drug | atorvastatin, dabigatran plus atorvastatin |
Primary outcome
Area under the concentration-time curve of the analyte in plasma at steady state over one dosing interval ( AUCτ,ss)
Time frame: Day 4
Maximum concentration of the analyte in plasma at steady state (Cmax,ss)
Time frame: 2 hours before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after drug administration on day 4
23 secondary outcomes
Area under the concentration-time curve of the analyte in plasma from the time point 0 after the last dose at steady state to the last quantifiable analyte plasma concentration within the uniform dosing interval τ (AUC0-tz,ss)
Time frame: Up to day 7 after administration
Time of last measurable concentration of the analyte in plasma within the dosing interval τ at steady state (tz,ss)
Time frame: Up to day 7 after administration
Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time frame: Up to day 7 after administration
Apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration (CL/Fss)
Time frame: Up to day 7 after administration
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: 2 hours before and 0,5, 1, 1,5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after drug administration
Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (tmin,ss )
Time frame: Up to day 7 after administration
Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Time frame: 2 hours before drug administration on day 1, 2, 3 and 4
Mean residence time of the analyte in the body at steady state after p.o. administration (MRTp.o.,ss)
Time frame: Up to day 7 after administration
Apparent volume of distribution during the terminal phase λz at steady state following an extravascular administration (Vz/Fss)
Time frame: Up to day 7 after administration
Amount of analyte that was eliminated in urine at steady state over an uniform dosing interval τ (Aeτ,ss)
Time frame: Day 4 and 5 after administration
Fraction of parent drug eliminated in urine at steady state over a uniform dosing interval τ (feτ,ss)
Time frame: Day 4 and 5 after administration
Renal clearance of the analyte at steady state determined over the dosing interval τ (CLR,ss)
Time frame: Day 4 and 5 after administration
Maximum effect ratio at steady state (ERmax_ss) for activated thrombin time (aPTT) and ecarin clotting time (ECT)
Time frame: Up to day 7 after administration
Area under the effect curve (baseline corrected) (AUECτ,ss) for aPTT and ECT
Time frame: Day 4 and 5
Change from baseline in blood pressure and puls rate (BP, PR)
Time frame: Baseline, day 78
Change from baseline in physical examination
Time frame: Baseline, day 78
Change from baseline in 12-lead electrocardiogram
Time frame: Baseline, day 78
Change from baseline in clinical laboratory tests
Time frame: Baseline, day 78
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to day 78
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Time frame: Day 78
Ecarin clotting time (ECT) prolongation at trough (ER(pre,ss))
Time frame: Up to day 7 after administration
Amount of total active HMG-CoA reductase inhibitors in plasma
Time frame: Up to day 7 after administration
Activated partial thromboplastin time (aPTT) prolongation at trough (ER(pre,ss))
Time frame: Up to day 7 after 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 31 Aug 2018.
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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 Dabigatran and Atorvastatin 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 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 31 Aug 2018. 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 the analyte in plasma at steady state over one dosing interval ( AUCτ,ss) (time frame: Day 4). 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 31 Aug 2018.