Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

Novartis

Status and phase: Completed; Phase 1

Conditions: Coronary Heart Disease

Treatments: Drug: Placebo; Drug: APL180

Study type: Interventional

Funder types: Industry

Identifiers

NCT00907998

CAPL180A2210B

EudraCT 2009-010877-19

Details and patient eligibility

About

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

Enrollment: 104 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 3 patient groups, including a placebo group

APL180 (first dose level)

Experimental group

Treatment:

Drug: APL180

Drug: APL180

APL180 (second dose level)

Experimental group

Treatment:

Drug: APL180

Drug: APL180

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo