Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

Phase 1

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: APL180; Drug: Placebo

• Registration Number: NCT00907998
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The design of this study will enable an extensive evaluation of safety, tolerability, and PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Study Start: 2009-06
• Primary Completion: 2009-10
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-19
• Last Update Posted: 2009-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Male and female CHD or CHD equivalent patients
• Body mass index (BMI) must be within the range of 20 to 35 kg/m2,
• Patient must have been on a stable statin therapy for >8 weeks prior to first dose except for the statin intolerant patients.

Exclusion criteria:

• Pregnancy
• Significant illness within two weeks prior to dosing.
• Triglycerides ≥ 500 mg/dl (5.65 mmol/l)
• Uncontrolled hypertension
• Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
• Presence of NYHA Class III or IV chronic heart failure
• MI or angioplasty (including stenting), acute coronary syndrome (ACS), unstable angina or arterial embolic disease within 6 months prior to do Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APL180 (first dose level)	APL180	-
APL180 (second dose level)	APL180	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of APL180	Throughout the study

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of APL180	Throughout the study
Evaluate effects of APL180 biomarkers	Throughout the study
Pharmacokinetic-pharmacodynamic relationship of APL180	Throughout the study
Effect of APL180 on exploratory biomarkers,	Throughout the study

Trial Locations

Locations (4)

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

Novartis Investigative Site; 🇺🇸 Philadelphia, Pennsylvania, United States

Icon Clinical Research; 🇺🇸 San Antonio, Texas, United States

Novartis Investigator Site; 🇳🇱 Amsterdam, Netherlands