DyslipidaemiaPhase 1NCT01632358
Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients
A Phase 1 study testing TAP311 capsules in people with Dyslipidaemia, run by Novartis Pharmaceuticals at 3 sites in 3 countries.
Trial summary
The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyslipidaemia
- What is being tested?
- TAP311 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2012to Dec 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 18 to 80 years (inclusive) of age.
- Patients are not treated for dyslipidemia with medications other than HMG-CoA reductase inhibitors (statins) for at least 4 weeks prior to Day 1. Patients should be on stable doses of current medications, if any, for at least 3 months to be eligible.
- Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2.
Who cannot join
- Use of other investigational drugs at the time of enrollment
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Use of lipid modifying agents (e.g. fenofibrate, niacin, omega-3 fatty acids, etc.) other than statins will exclude subjects.
- Pregnant or nursing (lactating) women
- Diabetic patients whose plasma glucose is not well controlled by stable diabetic treatment for at least 3 months
- Heavy smokers (smoke more than 10 cigarettes a day routinely and who cannot refrain from smoking during the study).
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- Women of child-bearing potential (WOCBP) can be included but must use highly effective contraception
- Significant illness within two (2) weeks prior to initial dosing
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Crossover Study to Assess Safety and Tolerability, Pharmacokinetics, and Explore Pharmacodynamics of TAP311 in Patients With Mixed Dyslipidaemia
The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.
- Conditions
- Dyslipidaemia
- Being tested
- TAP311 capsules, Placebo
- Keywords
- safety, tolerability, pharmacokinetics
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP311 capsulesDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TAP311 capsules | Experimental | Patients will receive TAP311 capsule orally once daily for 14 days. Receives: Drug: TAP311 capsules |
| Placebo of TAP311 capsules | Placebo comparator | Matching placebo to TAP311 capsule, once daily for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.
Measured: 14 days after treatment
Secondary outcomes (5)
Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss)
Day 1 - Cmax, Day 14 - Cmaxss, from the plasma concentration-time data. Each parameters will be one outcome measure
Measured: Day 1 and Day 14
Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)
The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)
Measured: Day 1 and Day 14 profile
Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Measured: Day 1
Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data
The Racc ratio from the plasma concentration-time data
Measured: Day 14
Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data
The AUCtau, from the plasma concentration-time data
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidaemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632358
- Sponsor's protocol ID
- CTAP311X2201
- Other IDs
- 2012-000857-29
- Status last verified
- Nov 2013
- First submitted
- 28 Jun 2012
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Crossover Study to Assess Safety and Tolerability, Pharmacokinetics, and Explore Pharmacodynamics of TAP311 in Patients With Mixed Dyslipidaemia
- ClinicalTrials.gov ID
- NCT01632358
- Acronym / sponsor ID
- CTAP311X2201
- Conditions
- Dyslipidaemia
- Keywords
- safety, tolerability, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Jul 2012 (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.
The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP311 capsules | Experimental | Drug: TAP311 capsulesPatients will receive TAP311 capsule orally once daily for 14 days. |
| Placebo of TAP311 capsules | Placebo comparator | Drug: PlaceboMatching placebo to TAP311 capsule, once daily for 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients 18 to 80 years (inclusive) of age.
- Patients are not treated for dyslipidemia with medications other than HMG-CoA reductase inhibitors (statins) for at least 4 weeks prior to Day 1. Patients should be on stable doses of current medications, if any, for at least 3 months to be eligible.
- Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2.
Key exclusion criteria (10 listed)
- Use of other investigational drugs at the time of enrollment
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Use of lipid modifying agents (e.g. fenofibrate, niacin, omega-3 fatty acids, etc.) other than statins will exclude subjects.
- Pregnant or nursing (lactating) women
- Diabetic patients whose plasma glucose is not well controlled by stable diabetic treatment for at least 3 months
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 |
|---|---|---|
| TAP311 capsules | Drug | TAP311 capsules |
| Placebo | Drug | Placebo of TAP311 capsules |
Primary outcome
Number of patients with adverse events
Time frame: 14 days after treatment
Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.
5 secondary outcomes
Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss)
Time frame: Day 1 and Day 14
Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)
Time frame: Day 1 and Day 14 profile
Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Day 1
Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data
Time frame: Day 14
Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data
Time frame: Day 14
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 2 Dec 2013.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAP311 capsules in people with Dyslipidaemia, run by Novartis Pharmaceuticals at 3 sites in 3 countries.
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 3 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 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Jordan, Taiwan. 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. Some participants in this study may receive a placebo. 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 adverse events (time frame: 14 days after treatment). 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 2 Dec 2013.