PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02359344

Enrollment

Registered

2015-02-10

Start date

2015-02-03

Completion date

2015-04-20

Last updated

2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Neuralgia

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.

Interventions

DRUGCNV1014802

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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/

Design outcomes

Primary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026