DyslipidemiaPhase 1NCT01487460
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
A Phase 1 study testing TAP311 in people with Dyslipidemia and Healthy Volunteers, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia, Healthy Volunteers
- What is being tested?
- TAP311
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects age 18 to 65 years of age included, and in good health as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
- OR untreated dyslipidemic patients.
- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Who cannot join
- Use of other investigational drugs at the time of enrollment.
- Active treatment for type 1 diabetes or type 2 diabetes mellitus.
- A past medical history of ECG abnormalities, documented cardiac arrhythmias or cardiovascular diseases.
- History of malignancy of any organ system, treated or untreated, within the past 5 years.
- Pregnant or nursing (lactating) women.
- Smokers.
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- Use of any prescription drugs, herbal supplements and/or over-the-counter (OTC) medication, dietary supplements.
- History of drug or alcohol abuse within the 12 months prior to dosing.
- Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-human Randomized, Double-blind, Placebo-controlled, 4-part Study to Assess Safety, Tolerability, Pharmacokinetics (Including Open Label Study of Food Effect and Interaction With Simvastatin) and Pharmacodynamics of Interwoven Single- and Multiple-ascending Doses of TAP311 in Healthy Subjects and Dyslipidemic Patients.
This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers.
- Conditions
- Dyslipidemia, Healthy Volunteers
- Being tested
- TAP311
- Keywords
- High cholesterol levels, Hyperlipidemia, High-density Lipoprotein, Low-density Lipoprotein, Simvastatin
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP311Drug
| Study group | Role | What they receive |
|---|---|---|
| TAP311 in Healthy Volunteers | Experimental | Not described Receives: Drug: TAP311 |
| Matching Placebo | Placebo comparator | Healthy Volunteers and Patients will be treated in Placebo group. Receives: Drug: TAP311 |
| TAP311 and Simvastatin | Experimental | Not described Receives: Drug: TAP311 |
| TAP311 in Patients | Experimental | Not described Receives: Drug: TAP311 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single and multiple doses of TAP311 in healthy subjects and patients with dyslipidemia
Number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).
Measured: Up to 21 days
Secondary outcomes (7)
TAP311 concentrations in blood and urine following administration of single and multiple doses in healthy subjects and in patients with dyslipidemia.
Measured: 25 timepoints over 17 days
Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects.
Simvastatin (and metabolite) blood concentration before and after TAP311 treatment.
Measured: 10 days
Effect of food on TAP311 blood concentration in healthy subjects.
TAP311 blood concentration when the drug is administered with and without food.
Measured: 3 days
Effects of TAP311 on total cholesterol in patients with dyslipidemia
Total cholesterol blood concentration before and after TAP311 treatment.
Measured: 8 timepoints over 15 days
Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia
LDL-C blood concentration before and after TAP311 treatment.
Measured: 8 timepoints over 15 days
Effects of TAP311 on high density lipoprotein (HDL-C)in patients with dyslipidemia.
HDL-C blood concentration before and after TAP311 treatment.
Measured: 8 timepoints over 15 days
Effects of TAP311 on triglycerides in patients with Dyslipidemia
Triglycerides concentration in blood before and after TAP311 treatment.
Measured: 8 timepoints over 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 137 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
- NCT01487460
- Sponsor's protocol ID
- CTAP311X2101
- Status last verified
- Apr 2016
- First submitted
- 28 Nov 2011
- Last updated
- 21 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human Randomized, Double-blind, Placebo-controlled, 4-part Study to Assess Safety, Tolerability, Pharmacokinetics (Including Open Label Study of Food Effect and Interaction With Simvastatin) and Pharmacodynamics of Interwoven Single- and Multiple-ascending Doses of TAP311 in Healthy Subjects and Dyslipidemic Patients.
- ClinicalTrials.gov ID
- NCT01487460
- Acronym / sponsor ID
- CTAP311X2101
- Conditions
- Dyslipidemia, Healthy Volunteers
- Keywords
- High cholesterol levels, Hyperlipidemia, High-density Lipoprotein, Low-density Lipoprotein, Simvastatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Dec 2011 (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.
This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TAP311 in Healthy Volunteers | Experimental | Drug: TAP311 |
| Matching Placebo | Placebo comparator | Drug: TAP311Healthy Volunteers and Patients will be treated in Placebo group. |
| TAP311 and Simvastatin | Experimental | Drug: TAP311 |
| TAP311 in Patients | Experimental | Drug: TAP311 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects age 18 to 65 years of age included, and in good health as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
- OR untreated dyslipidemic patients.
- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Key exclusion criteria (10 listed)
- Use of other investigational drugs at the time of enrollment.
- Active treatment for type 1 diabetes or type 2 diabetes mellitus.
- A past medical history of ECG abnormalities, documented cardiac arrhythmias or cardiovascular diseases.
- History of malignancy of any organ system, treated or untreated, within the past 5 years.
- Pregnant or nursing (lactating) women.
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 | Drug | Matching Placebo, TAP311 and Simvastatin, TAP311 in Healthy Volunteers, TAP311 in Patients |
Primary outcome
Safety and tolerability of single and multiple doses of TAP311 in healthy subjects and patients with dyslipidemia
Time frame: Up to 21 days
Number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).
7 secondary outcomes
TAP311 concentrations in blood and urine following administration of single and multiple doses in healthy subjects and in patients with dyslipidemia.
Time frame: 25 timepoints over 17 days
Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects.
Time frame: 10 days
Effect of food on TAP311 blood concentration in healthy subjects.
Time frame: 3 days
Effects of TAP311 on total cholesterol in patients with dyslipidemia
Time frame: 8 timepoints over 15 days
Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia
Time frame: 8 timepoints over 15 days
Effects of TAP311 on high density lipoprotein (HDL-C)in patients with dyslipidemia.
Time frame: 8 timepoints over 15 days
Effects of TAP311 on triglycerides in patients with Dyslipidemia
Time frame: 8 timepoints over 15 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 21 Dec 2020.
- Results for CTAP311X2101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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
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 TAP311 in people with Dyslipidemia and Healthy Volunteers, run by Novartis Pharmaceuticals at 1 site in United States.
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 21 Dec 2020. 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 United States. 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?
Safety and tolerability of single and multiple doses of TAP311 in healthy subjects and patients with dyslipidemia (time frame: Up to 21 days). 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 21 Dec 2020.