PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

Phase 1

Completed

• Conditions: Trigeminal Neuralgia
• Interventions: Drug: CNV1014802; Drug: Placebo

• Registration Number: NCT02359344
• Lead Sponsor: Biogen

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.

Study Timeline

• Study First Submitted: 2015-02-02
• Study Start: 2015-02-03
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-10
• Primary Completion: 2015-04-20
• Study Completion: 2015-04-20
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CNV1014802	CNV1014802	CNV1014802 150mg three times a day (tid) 7 days plus a single dose on day 8
Placebo	Placebo	Placebo tid 7 days plus a single dose on day 8

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Parexel International; 🇬🇧 London, United Kingdom