PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

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

Official Title
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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

Conditions
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Trigeminal Neuralgia

Intervention / Treatment
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* Drug: CNV1014802
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CNV1014802<br>CNV1014802 150mg three times a day (tid) 7 days plus a single dose on day 8 | Drug: CNV1014802<br> <br> * Other names: BIIB074;|
| Placebo Comparator: Placebo<br>Placebo tid 7 days plus a single dose on day 8 | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Concentration |  | 9 days | 
| Area under the concentration curve |  | 9 days | 
| Minimum concentration |  | 9 days | 
| Frequency of adverse events |  | 9 days | 
| Change in vital signs compared to baseline |  | 9 days | 
| Change in 12-lead ECG parameters compared to baseline |  | 9 days | 
| Change in safety lab parameters compared to baseline |  | 9 days |