Absorption, Metabolism, and Excretion Study of BIIB074

NCT ID: NCT02751905

Last Updated: 2016-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-05-31

Brief Summary

The primary objectives of the study are: To determine the mass balance and routes of elimination of BIIB074 and its known metabolites following administration of a single oral dose of BIIB074 in healthy male participants and To describe the pharmacokinetics (PK) of BIIB074 and its known metabolites and the disposition profiles of total radioactivity in whole blood and plasma following a single oral dose. The secondary objectives of this study are: To assess the safety and tolerability of BIIB074 in healthy participants and To identify and characterize any additional metabolites of BIIB074 in plasma, urine, and feces.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIIB074

Single oral dose on Day 1

Group Type: EXPERIMENTAL

BIIB074

Intervention Type: DRUG

Administered orally as specified in treatment arm

Interventions

BIIB074

Administered orally as specified in treatment arm

Intervention Type: DRUG

Other Intervention Names

CNV1014802

Eligibility Criteria

Inclusion Criteria

• All subjects must practice effective contraception during the study and be willing and able to continue contraception for 90 days after the administration of study treatment.
• Must be in good health as determined by the Investigator, based on medical history and screening evaluations.

Exclusion Criteria

• History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
• Previous exposure to BIIB074.
• Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

802HV105

Identifier Type: -

Identifier Source: org_study_id