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Completed

NCT Number: NCT02359344

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 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.

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International

London, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CNV1014802

Drug

Other names: BIIB074

Placebo

Drug

Primary outcomes

  1. Maximum Concentration

    Time frame: 9 days

  2. Area under the concentration curve

    Time frame: 9 days

  3. Minimum concentration

    Time frame: 9 days

  4. Frequency of adverse events

    Time frame: 9 days

  5. Change in vital signs compared to baseline

    Time frame: 9 days

  6. Change in 12-lead ECG parameters compared to baseline

    Time frame: 9 days

  7. Change in safety lab parameters compared to baseline

    Time frame: 9 days

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 10, 2015
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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