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PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

NCT ID: NCT02359344

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-03

Study Completion Date

2015-04-20

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.

Conditions

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Trigeminal Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CNV1014802

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

Group Type EXPERIMENTAL

CNV1014802

Intervention Type DRUG

Placebo

Placebo tid 7 days plus a single dose on day 8

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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CNV1014802

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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BIIB074

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Parexel International

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2014-004980-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1014802/101

Identifier Type: -

Identifier Source: org_study_id