NCT01632358

Brief Summary

The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
279

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1

Geographic Reach
3 countries

3 active sites

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

June 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 2, 2013

Status Verified

November 1, 2013

Enrollment Period

6 months

First QC Date

June 28, 2012

Last Update Submit

November 27, 2013

Conditions

Dyslipidaemia

Keywords

safetytolerabilitypharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.

    14 days after treatment

Secondary Outcomes (5)

  • Pharmacokinetics of TAP311: The observed maximum plasma concentration following drug administration at steady state (Cmax,ss)

    Day 1 and Day 14

  • Pharmacokinetics of TAP311: The time to reach the maximum concentration after drug administration at steady state(Tmax, ss)

    Day 1 and Day 14 profile

  • Pharmacokinetics of TAP311: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)

    Day 1

  • Pharmacokinetics of TAP311: The Racc ratio from the plasma concentration-time data

    Day 14

  • Pharmacokinetics of TAP311: The AUCtau, from the plasma concentration-time data

    Day 14

Study Arms (2)

TAP311 capsules

EXPERIMENTAL

Patients will receive TAP311 capsule orally once daily for 14 days.

Drug: TAP311 capsules

Placebo of TAP311 capsules

PLACEBO COMPARATOR

Matching placebo to TAP311 capsule, once daily for 14 days

Drug: Placebo

Interventions

TAP311 capsulesDRUG
TAP311 capsules
PlaceboDRUG
Placebo of TAP311 capsules

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients 18 to 80 years (inclusive) of age.
  • Patients are not treated for dyslipidemia with medications other than HMG-CoA reductase inhibitors (statins) for at least 4 weeks prior to Day 1. Patients should be on stable doses of current medications, if any, for at least 3 months to be eligible.
  • Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2.

You may not qualify if:

  • Use of other investigational drugs at the time of enrollment
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
  • Use of lipid modifying agents (e.g. fenofibrate, niacin, omega-3 fatty acids, etc.) other than statins will exclude subjects.
  • Pregnant or nursing (lactating) women
  • Diabetic patients whose plasma glucose is not well controlled by stable diabetic treatment for at least 3 months
  • Heavy smokers (smoke more than 10 cigarettes a day routinely and who cannot refrain from smoking during the study).
  • Women of child-bearing potential (WOCBP) can be included but must use highly effective contraception
  • Significant illness within two (2) weeks prior to initial dosing
  • History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
  • A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Miramar, Florida, 33025, United States

Location

Novartis Investigative Site

Amman, 11941, Jordan

Location

Novartis Investigative Site

Taichung, Taiwan, 40447, Taiwan

Location

MeSH Terms

Conditions

Dyslipidemias

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
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 2, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 2, 2013

Record last verified: 2013-11

Locations

US(1)JO(1)TW(1)