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
Overview
- Phase
- Phase 1
- Intervention
- CNV1014802
- Conditions
- Trigeminal Neuralgia
- Sponsor
- Biogen
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Minimum concentration
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed Description
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and female over 18 years using acceptable methods of contraception
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
Arms & Interventions
CNV1014802
CNV1014802 150mg three times a day (tid) 7 days plus a single dose on day 8
Intervention: CNV1014802
Placebo
Placebo tid 7 days plus a single dose on day 8
Intervention: Placebo
Outcomes
Primary Outcomes
Minimum concentration
Time Frame: 9 days
Maximum Concentration
Time Frame: 9 days
Area under the concentration curve
Time Frame: 9 days
Frequency of adverse events
Time Frame: 9 days
Change in vital signs compared to baseline
Time Frame: 9 days
Change in 12-lead ECG parameters compared to baseline
Time Frame: 9 days
Change in safety lab parameters compared to baseline
Time Frame: 9 days