PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

A Randomized, Double-blind, Placebo Controlled, Two Period Crossover Study to Investigate the Pharmacokinetics, Tolerability and Cognitive Effects of an Oral Dose Regimen of 150mg Tid CNV1014802 in Healthy Young Versus Elderly Male and Female Subjects

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.

This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

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