PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

Biogen

Status and phase: Completed; Phase 1

Conditions: Trigeminal Neuralgia

Treatments: Drug: CNV1014802; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02359344

2014-004980-19 (EudraCT Number)

1014802/101

Details and patient eligibility

About

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.

Full description

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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

CNV1014802

Experimental group

Description:

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

Treatment:

Drug: CNV1014802

Placebo

Placebo Comparator group

Description:

Placebo tid 7 days plus a single dose on day 8

Treatment:

Drug: Placebo