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PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

Primary Purpose

Trigeminal Neuralgia

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

CNV1014802

Placebo

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Parexel International

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CNV1014802

Placebo

Arm Description

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

Placebo tid 7 days plus a single dose on day 8

Outcomes

Primary Outcome Measures

Maximum Concentration

Area under the concentration curve

Minimum concentration

Frequency of adverse events

Change in vital signs compared to baseline

Change in 12-lead ECG parameters compared to baseline

Change in safety lab parameters compared to baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT02359344

First Posted

February 2, 2015

Last Updated

October 10, 2017

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT02359344

Brief Title

PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

February 3, 2015 (Actual)

Primary Completion Date

April 20, 2015 (Actual)

Study Completion Date

April 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigeminal Neuralgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CNV1014802

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tid 7 days plus a single dose on day 8

Intervention Type

Drug

Intervention Name(s)

CNV1014802

Other Intervention Name(s)

BIIB074

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Maximum Concentration

Time Frame

9 days

Title

Area under the concentration curve

Time Frame

9 days

Title

Minimum concentration

Time Frame

9 days

Title

Frequency of adverse events

Time Frame

9 days

Title

Change in vital signs compared to baseline

Time Frame

9 days

Title

Change in 12-lead ECG parameters compared to baseline

Time Frame

9 days

Title

Change in safety lab parameters compared to baseline

Time Frame

9 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Parexel International

City

London

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

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