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

Healthy Volunteers Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487460
• Other study ID #: CTAP311X2101
• Status: Completed
• Phase: Phase 1
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Healthy Volunteers

Intervention

Drug:
• TAP311

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Miramar	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Effect of TAP311 administration on simvastatin (and metabolite) blood concentration in healthy subjects.	Simvastatin (and metabolite) blood concentration before and after TAP311 treatment.	10 days
Secondary	Effect of food on TAP311 blood concentration in healthy subjects.	TAP311 blood concentration when the drug is administered with and without food.	3 days
Secondary	Effects of TAP311 on total cholesterol in patients with dyslipidemia	Total cholesterol blood concentration before and after TAP311 treatment.	8 timepoints over 15 days
Secondary	Effects of TAP311 on Low Density Lipoprotein (LDL-C) in patients with dyslipidemia	LDL-C blood concentration before and after TAP311 treatment.	8 timepoints over 15 days
Secondary	Effects of TAP311 on high density lipoprotein (HDL-C)in patients with dyslipidemia.	HDL-C blood concentration before and after TAP311 treatment.	8 timepoints over 15 days
Secondary	Effects of TAP311 on triglycerides in patients with Dyslipidemia	Triglycerides concentration in blood before and after TAP311 treatment.	8 timepoints over 15 days

External Links

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