Absorption, Metabolism, and Excretion Study of BIIB074

A Phase 1, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-BIIB074 in Healthy Male Subjects

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 Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: BIIB074

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIIB074; Single oral dose on Day 1	Drug: BIIB074; Administered orally as specified in treatment arm; Other Names: CNV1014802

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary amount excreted per sampling interval (Aeu)	12 hours prior to dosing up to Day 9
Fecal amount excreted per sampling interval (Aef)	Prior to dosing up to Day 9
Cumulative urinary amount excreted per sampling interval (Cum Aeu)	12 hours prior to dosing up to Day 9
Cumulative fecal amount excreted per sampling interval (Cum Aef)	Prior to dosing up to Day 9
Percentage of radioactive urinary dose excreted per sampling interval (%Feu)	12 hours prior to dosing up to Day 9
Percentage of radioactive fecal dose excreted per sampling interval (%Fef)	Prior to dosing up to Day 9
Cumulative percentage of radioactive urinary dose excreted per sampling interval (Cum %Feu)	12 hours prior to dosing up to Day 9
Cumulative percentage of radioactive fecal dose excreted per sampling interval (Cum %Fef)	Prior to dosing up to Day 9
Urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Aeu)	12 hours prior to dosing up to Day 9
Cumulative urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Cum Aeu)	12 hours prior to dosing up to Day 9
Percentage of BIIB074 dose excreted per sampling interval (%Feu)	12 hours prior to dosing up to Day 9
Cumulative percentage of BIIB074 dose excreted (Cum %Feu)	12 hours prior to dosing up to Day 9
Maximum observed concentration (Cmax)	2 hours post dose up to Day 9
Time to reach Cmax (Tmax)	2 hours post dose up to Day 9
Area under the concentration-time curve from time 0 to time of the last measurable drug concentration (AUC0-t)	2 hours post dose up to Day 9
Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)	2 hours post dose up to Day 9
Terminal elimination half-life (t1/2)	2 hours post dose up to Day 9
Apparent total body clearance (CL/F)	2 hours post dose up to Day 9
Apparent volume of distribution (Vd/F)	2 hours post dose up to Day 9
Renal clearance (CLR)	2 hours post dose up to Day 9
Metabolite-to-parent ratio at Cmax (MRCmax)	2 hours post dose up to Day 9
Metabolite-to-parent ratio in AUC (MRAUC)	2 hours post dose up to Day 9

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)	Up to Day 9
Number of participants with clinically significant vital sign abnormalities	Up to Day 9
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities	Up to Day 9
Number of participants with clinically significant laboratory assessment abnormalities	Up to Day 9
Radioactivity profiles in plasma, urine and feces	Up to Day 9

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: 802HV105