Back to resultsSafety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
Primary Purpose
Dyslipidemia, Healthy Volunteers
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TAP311
Sponsored by
About this trial
This is an interventional other trial for Dyslipidemia focused on measuring High cholesterol levels, Hyperlipidemia, High-density Lipoprotein, Low-density Lipoprotein, Simvastatin
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
TAP311 in Healthy Volunteers
Matching Placebo
TAP311 and Simvastatin
TAP311 in Patients
Arm Description
Healthy Volunteers and Patients will be treated in Placebo group.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
TAP311 concentrations in blood and urine following administration of single and multiple doses in healthy subjects and in patients with dyslipidemia.
Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects.
Simvastatin (and metabolite) blood concentration before and after TAP311 treatment.
Effect of food on TAP311 blood concentration in healthy subjects.
TAP311 blood concentration when the drug is administered with and without food.
Effects of TAP311 on total cholesterol in patients with dyslipidemia
Total cholesterol blood concentration before and after TAP311 treatment.
Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia
LDL-C blood concentration before and after TAP311 treatment.
Effects of TAP311 on high density lipoprotein (HDL-C)in patients with dyslipidemia.
HDL-C blood concentration before and after TAP311 treatment.
Effects of TAP311 on triglycerides in patients with Dyslipidemia
Triglycerides concentration in blood before and after TAP311 treatment.
Full Information
NCT ID
NCT01487460
First Posted
November 28, 2011
Last Updated
December 17, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01487460
Brief Title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Healthy Volunteers
Keywords
High cholesterol levels, Hyperlipidemia, High-density Lipoprotein, Low-density Lipoprotein, Simvastatin
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAP311 in Healthy Volunteers
Arm Type
Experimental
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Healthy Volunteers and Patients will be treated in Placebo group.
Arm Title
TAP311 and Simvastatin
Arm Type
Experimental
Arm Title
TAP311 in Patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TAP311
Primary Outcome Measure Information:
Title
Safety and tolerability of single and multiple doses of TAP311 in healthy subjects and patients with dyslipidemia
Description
Number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).
Time Frame
Up to 21 days
Secondary Outcome Measure Information:
Title
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
Title
Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects.
Description
Simvastatin (and metabolite) blood concentration before and after TAP311 treatment.
Time Frame
10 days
Title
Effect of food on TAP311 blood concentration in healthy subjects.
Description
TAP311 blood concentration when the drug is administered with and without food.
Time Frame
3 days
Title
Effects of TAP311 on total cholesterol in patients with dyslipidemia
Description
Total cholesterol blood concentration before and after TAP311 treatment.
Time Frame
8 timepoints over 15 days
Title
Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia
Description
LDL-C blood concentration before and after TAP311 treatment.
Time Frame
8 timepoints over 15 days
Title
Effects of TAP311 on high density lipoprotein (HDL-C)in patients with dyslipidemia.
Description
HDL-C blood concentration before and after TAP311 treatment.
Time Frame
8 timepoints over 15 days
Title
Effects of TAP311 on triglycerides in patients with Dyslipidemia
Description
Triglycerides concentration in blood before and after TAP311 treatment.
Time Frame
8 timepoints over 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9083
Description
Results for CTAP311X2101 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
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