Absorption, Metabolism, and Excretion Study of BIIB074

NCT02751905 | Completed Phase 1

• 1 other identifier: 802HV105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (22)

• 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 Outcomes (5)

• 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

Study Arms (1)

BIIB074

EXPERIMENTAL

Single oral dose on Day 1

Drug: BIIB074

Interventions

BIIB074 DRUG

Administered orally as specified in treatment arm

Also known as: CNV1014802

BIIB074

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Neuralgia

Interventions

vixotrigine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 26, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2016-06

Locations

US (1)