Overview

Absorption, Metabolism, and Excretion Study of BIIB074

Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Biogen
Criteria
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.