Absorption, Metabolism, and Excretion Study of BIIB074

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751905
• Other study ID #: 802HV105
• Status: Completed
• Phase: Phase 1
• First received: April 22, 2016
• Last updated: June 15, 2016
• Start date: April 2016
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• BIIB074
Administered orally as specified in treatment arm

Locations

Country	Name	City	State
United States	Research Site	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary amount excreted per sampling interval (Aeu)		12 hours prior to dosing up to Day 9	No
Primary	Fecal amount excreted per sampling interval (Aef)		Prior to dosing up to Day 9	No
Primary	Cumulative urinary amount excreted per sampling interval (Cum Aeu)		12 hours prior to dosing up to Day 9	No
Primary	Cumulative fecal amount excreted per sampling interval (Cum Aef)		Prior to dosing up to Day 9	No
Primary	Percentage of radioactive urinary dose excreted per sampling interval (%Feu)		12 hours prior to dosing up to Day 9	No
Primary	Percentage of radioactive fecal dose excreted per sampling interval (%Fef)		Prior to dosing up to Day 9	No
Primary	Cumulative percentage of radioactive urinary dose excreted per sampling interval (Cum %Feu)		12 hours prior to dosing up to Day 9	No
Primary	Cumulative percentage of radioactive fecal dose excreted per sampling interval (Cum %Fef)		Prior to dosing up to Day 9	No
Primary	Urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Aeu)		12 hours prior to dosing up to Day 9	No
Primary	Cumulative urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Cum Aeu)		12 hours prior to dosing up to Day 9	No
Primary	Percentage of BIIB074 dose excreted per sampling interval (%Feu)		12 hours prior to dosing up to Day 9	No
Primary	Cumulative percentage of BIIB074 dose excreted (Cum %Feu)		12 hours prior to dosing up to Day 9	No
Primary	Maximum observed concentration (Cmax)		2 hours post dose up to Day 9	No
Primary	Time to reach Cmax (Tmax)		2 hours post dose up to Day 9	No
Primary	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	No
Primary	Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)		2 hours post dose up to Day 9	No
Primary	Terminal elimination half-life (t1/2)		2 hours post dose up to Day 9	No
Primary	Apparent total body clearance (CL/F)		2 hours post dose up to Day 9	No
Primary	Apparent volume of distribution (Vd/F)		2 hours post dose up to Day 9	No
Primary	Renal clearance (CLR)		2 hours post dose up to Day 9	No
Primary	Metabolite-to-parent ratio at Cmax (MRCmax)		2 hours post dose up to Day 9	No
Primary	Metabolite-to-parent ratio in AUC (MRAUC)		2 hours post dose up to Day 9	No
Secondary	Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)		Up to Day 9	Yes
Secondary	Number of participants with clinically significant vital sign abnormalities		Up to Day 9	Yes
Secondary	Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities		Up to Day 9	Yes
Secondary	Number of participants with clinically significant laboratory assessment abnormalities		Up to Day 9	Yes
Secondary	Radioactivity profiles in plasma, urine and feces		Up to Day 9	No