Healthy VolunteersPhase 1D-cocktailNCT02361619
Dabigatran in an Interaction Probe Drug Cocktail
A Phase 1 study testing Caffeine, Diclofenac and Esomeprazole in people with Healthy Volunteers, run by Turku University Hospital at 1 site in Finland.
Trial summary
Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Caffeine, Diclofenac and Esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2015to Jun 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Weight at least 50 kg and body mass index 19 - 30 kg m-2
- Normal clinical laboratory profiles
- No childbearing potential or use of adequate contraceptive measures
Who cannot join
- Blood loss >300 ml within 2 months prior to the first dosing day
- Pregnancy, breastfeeding
- Allergy or hypersensitivity to caffeine, diclofenac, esomeprazole, metoprolol, midazolam, dabigatran or clarithromycin or to excipients in the pharmaceutical products
- Infection with HIV, HBV or HCV
- Participation in the preceding 3 months or concomitantly in any clinical drug study
- Suspected current drug or alcohol abuse
Show all 10Show fewer
- History of drug or alcohol abuse.
- Concomitant medication with the exception of hormonal contraception.
- Positive result in urine test for drug abuse.
- Nicotine consumption equivalent to >5 cigarettes per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Crossover Trial Assessing the Value of Dabigatran in a Drug Interaction Cocktail in Healthy Young Volunteers
Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.
- Conditions
- Healthy Volunteers
- Being tested
- Caffeine, Diclofenac, Esomeprazole, Metoprolol, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
probe
DiclofenacDrug
probe
EsomeprazoleDrug
probe
MetoprololDrug
probe
MidazolamDrug
probe
DabigatranDrug
probe
ClarithromycinDrug
perpetrator
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Caffeine; Drug: Diclofenac; Drug: Esomeprazole; Drug: Metoprolol; Drug: Midazolam; Drug: Dabigatran; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of dabigatran in plasma
Exposure ratio for dabigatran in combination and dabigatran alone
Measured: 24 h
Secondary outcomes (1)
Number of subjects with adverse events
Measured: 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Petri Vainio, MD PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361619
- Sponsor's protocol ID
- T162/2014
- Other IDs
- 2014-003628-38, 2014
- Acronym
- D-cocktail
- Status last verified
- Aug 2018
- First submitted
- 30 Jan 2015
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Crossover Trial Assessing the Value of Dabigatran in a Drug Interaction Cocktail in Healthy Young Volunteers
- ClinicalTrials.gov ID
- NCT02361619
- Acronym / sponsor ID
- D-cocktail / T162/2014
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Feb 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Feb 2015 (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.
Four periods of oral dosing following overnight fasting (1. known metabolic probe drug cocktail consisting of caffeine, diclofenac, esomeprazole, metoprolol, midazolam; 2. dabigatran + cocktail; 3. dabigatran alone; 4. clarithromycin 3 days + cocktail + dabigatran). Blood samples collected for pharmacokinetics over 24 h. Washout between periods. Adverse events, haematology and clinical chemistry recorded.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Caffeine, Drug: Diclofenac, Drug: Esomeprazole, Drug: Metoprolol, Drug: Midazolam, Drug: Dabigatran, Drug: Clarithromycin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Weight at least 50 kg and body mass index 19 - 30 kg m-2
- Normal clinical laboratory profiles
- No childbearing potential or use of adequate contraceptive measures
Key exclusion criteria (10 listed)
- Blood loss >300 ml within 2 months prior to the first dosing day
- Pregnancy, breastfeeding
- Allergy or hypersensitivity to caffeine, diclofenac, esomeprazole, metoprolol, midazolam, dabigatran or clarithromycin or to excipients in the pharmaceutical products
- Infection with HIV, HBV or HCV
- Participation in the preceding 3 months or concomitantly in any clinical drug study
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 |
|---|---|---|
| Caffeineprobe | Drug | 1 |
| Diclofenacprobe | Drug | 1 |
| Esomeprazoleprobe | Drug | 1 |
| Metoprololprobe | Drug | 1 |
| Midazolamprobe | Drug | 1 |
| Dabigatranprobe | Drug | 1 |
| Clarithromycinperpetrator | Drug | 1 |
Primary outcome
AUC of dabigatran in plasma
Time frame: 24 h
Exposure ratio for dabigatran in combination and dabigatran alone
1 secondary outcome
Number of subjects with adverse events
Time frame: 23 days
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 14 Aug 2018.
Related trials for Healthy Volunteers
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
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Petri Vainio, MD PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Caffeine, Diclofenac and Esomeprazole in people with Healthy Volunteers, run by Turku University Hospital at 1 site in Finland.
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 10 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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
AUC of dabigatran in plasma (time frame: 24 h). 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 14 Aug 2018.