Absorption, Metabolism, and Excretion Study of BIIB074

Phase 1CompletedNCT02751905

Biogen6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuropathic Pain

Interventions

BIIB074DRUG

Administered orally as specified in treatment arm

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key 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. Key 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (1)

Research Site

Madison, Wisconsin, United States