PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

Trigeminal Neuralgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359344
• Other study ID #: 1014802/101
• Secondary ID: 2014-004980-19
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2015
• Last updated: October 10, 2017
• Start date: February 3, 2015
• Est. completion date: April 20, 2015

Study information

• Verified date: October 2017
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 20, 2015
• Est. primary completion date: April 20, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Drug:
• CNV1014802

• Placebo

Locations

Country	Name	City	State
United Kingdom	Parexel International	London

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Concentration		9 days
Primary	Area under the concentration curve		9 days
Primary	Minimum concentration		9 days
Primary	Frequency of adverse events		9 days
Primary	Change in vital signs compared to baseline		9 days
Primary	Change in 12-lead ECG parameters compared to baseline		9 days
Primary	Change in safety lab parameters compared to baseline		9 days