Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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