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

Novartis

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Dyslipidemia

Treatments: Drug: TAP311

Study type: Interventional

Funder types: Industry

Identifiers

NCT01487460

CTAP311X2101

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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137 participants in 4 patient groups, including a placebo group

TAP311 in Healthy Volunteers

Experimental group

Treatment:

Drug: TAP311

Matching Placebo

Placebo Comparator group

Description:

Healthy Volunteers and Patients will be treated in Placebo group.

Treatment:

Drug: TAP311

TAP311 and Simvastatin

Experimental group

Treatment:

Drug: TAP311

TAP311 in Patients

Experimental group

Treatment:

Drug: TAP311