NCT01487460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 21, 2020

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

November 28, 2011

Last Update Submit

December 17, 2020

Conditions

DyslipidemiaHealthy Volunteers

Keywords

High cholesterol levelsHyperlipidemiaHigh-density LipoproteinLow-density LipoproteinSimvastatin

Outcome Measures

Primary Outcomes (1)

  • 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).

    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.

    25 timepoints over 17 days

  • Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects.

    10 days

  • Effect of food on TAP311 blood concentration in healthy subjects.

    3 days

  • Effects of TAP311 on total cholesterol in patients with dyslipidemia

    8 timepoints over 15 days

  • Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia

    8 timepoints over 15 days

  • +2 more secondary outcomes

Study Arms (4)

TAP311 in Healthy Volunteers

EXPERIMENTAL
Drug: TAP311

Matching Placebo

PLACEBO COMPARATOR

Healthy Volunteers and Patients will be treated in Placebo group.

Drug: TAP311

TAP311 and Simvastatin

EXPERIMENTAL
Drug: TAP311

TAP311 in Patients

EXPERIMENTAL
Drug: TAP311

Interventions

TAP311DRUG
Matching PlaceboTAP311 and SimvastatinTAP311 in Healthy VolunteersTAP311 in Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Miramar, Florida, 33025, United States

Location

Related Links

MeSH Terms

Conditions

DyslipidemiasHypercholesterolemiaHyperlipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2011

First Posted

December 7, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 21, 2020

Record last verified: 2016-04

Locations

US(1)