Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age

• Status: Completed
• Trial end date: 2016-03-11
• Target enrollment: 0
• Participant gender: All

Summary

The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: CNP520

Criteria

Key Inclusion Criteria:

• Healthy status

• Body weight: ≥45kg

• BMI: 18-34 kg/m2

Key Exclusion Criteria:

• History or presence of any clinically significant disease of any major system organ class.

• Heavy smoker status

• History /presence of clinically significant neurological or psychiatric disorders

• Any medical condition that might lead to or is associated with any cognitive deficit

• History or presence of severely impaired renal function