PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

• Status: Completed
• Trial end date: 2015-04-20
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-blind, placebo controlled, two period crossover study to investigate the pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in healthy young versus elderly male and female subjects. Treatment periods will be separated by 13 days. The primary outcome measures are pharmacokinetics (PK) and tolerability.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biogen; Convergence Pharmaceuticals
• Collaborator: Parexel

Criteria

Key Inclusion Criteria:

• Healthy male and female over 18 years using acceptable methods of contraception

Key Exclusion Criteria:

• Positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody

• History or evidence of alcohol or drug abuse

• Pregnant or lactating females

• Participation in a clinical trial within 3 months or the current study or exposure to more than four new chemical entities within 12 months.

• Use of prohibited concomitant medication

• History or presence of any clinically significant abnormality in vital signs / ECG / laboratory tests, or have any medical or psychiatric condition, which, in the opinion of the Investigator may interfere with the study procedures or compromise subject safety.

• Relevant history of a suicide attempt or suicidal behavior

Note: Other protocol defined inclusion/exclusion criteria may apply