Healthy VolunteerPhase 1NCT01363999
A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers
A Phase 1 study testing atorvastatin and dalcetrapib in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in New Zealand.
Trial summary
A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- atorvastatin and dalcetrapib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNew Zealand
- Study dates
- Jun 2011to Jul 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 volunteers, 18 to 55 years of age, inclusive
Who cannot join
- Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the patient
- Clinically significant abnormal laboratory values
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Open-label, Four Treatments, Four Periods, Four Sequence, Four-way Crossover Study to Explore the Pharmacokinetic Performance of Dalcetrapib and Atorvastatin Fixed Dose Combination Prototype Formulations in Healthy Volunteers
A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.
- Conditions
- Healthy Volunteer
- Being tested
- atorvastatin, dalcetrapib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
single dose of atorvastatin on day 1
dalcetrapibDrug
single dose of dalcetrapib on day 1
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | RO5317116/F01 bilayer tablet Receives: Drug: atorvastatin; Drug: dalcetrapib |
| B | Experimental | RO5317116/F03 bilayer tablet Receives: Drug: atorvastatin; Drug: dalcetrapib |
| C | Experimental | RO5317116/F04 active-coated tablet Receives: Drug: atorvastatin; Drug: dalcetrapib |
| D | Experimental | RO4607381/F49 tablet Receives: Drug: atorvastatin; Drug: dalcetrapib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of Dalcetrapib Active Form
Measured: 3 days
Plasma Concentration of Atorvastatin
Measured: 3 days
Secondary outcomes (2)
Plasma Concentration of Atorvastatin Metabolites
Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma.
Measured: 3 days
Safety: Incidence of Serious Adverse Events
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363999
- Sponsor's protocol ID
- WP25642
- Status last verified
- Dec 2019
- First submitted
- 31 May 2011
- Last updated
- 17 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open-label, Four Treatments, Four Periods, Four Sequence, Four-way Crossover Study to Explore the Pharmacokinetic Performance of Dalcetrapib and Atorvastatin Fixed Dose Combination Prototype Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01363999
- Acronym / sponsor ID
- WP25642
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Posted 17 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: atorvastatin, Drug: dalcetrapibRO5317116/F01 bilayer tablet |
| B | Experimental | Drug: atorvastatin, Drug: dalcetrapibRO5317116/F03 bilayer tablet |
| C | Experimental | Drug: atorvastatin, Drug: dalcetrapibRO5317116/F04 active-coated tablet |
| D | Experimental | Drug: atorvastatin, Drug: dalcetrapibRO4607381/F49 tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers, 18 to 55 years of age, inclusive
Key exclusion criteria (2 listed)
- Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the patient
- Clinically significant abnormal laboratory values
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 |
|---|---|---|
| atorvastatinsingle dose of atorvastatin on day 1 | Drug | A, B, C, D |
| dalcetrapibsingle dose of dalcetrapib on day 1 | Drug | A, B, C, D |
Primary outcome
Plasma Concentration of Dalcetrapib Active Form
Time frame: 3 days
Plasma Concentration of Atorvastatin
Time frame: 3 days
2 secondary outcomes
Plasma Concentration of Atorvastatin Metabolites
Time frame: 3 days
Safety: Incidence of Serious Adverse Events
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
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 atorvastatin and dalcetrapib in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in New Zealand.
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 1 inclusion and 2 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 17 Dec 2019. 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 New Zealand. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plasma Concentration of Dalcetrapib Active Form (time frame: 3 days). 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 17 Dec 2019.