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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients

NCT ID: NCT01487460

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dyslipidemia Healthy Volunteers

Keywords

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High cholesterol levels Hyperlipidemia High-density Lipoprotein Low-density Lipoprotein Simvastatin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TAP311 in Healthy Volunteers

Group Type EXPERIMENTAL

TAP311

Intervention Type DRUG

Matching Placebo

Healthy Volunteers and Patients will be treated in Placebo group.

Group Type PLACEBO_COMPARATOR

TAP311

Intervention Type DRUG

TAP311 and Simvastatin

Group Type EXPERIMENTAL

TAP311

Intervention Type DRUG

TAP311 in Patients

Group Type EXPERIMENTAL

TAP311

Intervention Type DRUG

Interventions

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TAP311

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Miramar, Florida, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9083

Results for CTAP311X2101 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CTAP311X2101

Identifier Type: -

Identifier Source: org_study_id