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Absorption, Metabolism, and Excretion Study of BIIB074

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ClinicalTrials.gov Identifier: NCT02751905
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: BIIB074 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-BIIB074 in Healthy Male Subjects
Study Start Date : April 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: BIIB074
Single oral dose on Day 1
Drug: BIIB074
Administered orally as specified in treatment arm
Other Name: CNV1014802




Primary Outcome Measures :
  1. Urinary amount excreted per sampling interval (Aeu) [ Time Frame: 12 hours prior to dosing up to Day 9 ]
  2. Fecal amount excreted per sampling interval (Aef) [ Time Frame: Prior to dosing up to Day 9 ]
  3. Cumulative urinary amount excreted per sampling interval (Cum Aeu) [ Time Frame: 12 hours prior to dosing up to Day 9 ]
  4. Cumulative fecal amount excreted per sampling interval (Cum Aef) [ Time Frame: Prior to dosing up to Day 9 ]
  5. Percentage of radioactive urinary dose excreted per sampling interval (%Feu) [ Time Frame: 12 hours prior to dosing up to Day 9 ]
  6. Percentage of radioactive fecal dose excreted per sampling interval (%Fef) [ Time Frame: Prior to dosing up to Day 9 ]
  7. Cumulative percentage of radioactive urinary dose excreted per sampling interval (Cum %Feu) [ Time Frame: 12 hours prior to dosing up to Day 9 ]
  8. Cumulative percentage of radioactive fecal dose excreted per sampling interval (Cum %Fef) [ Time Frame: Prior to dosing up to Day 9 ]
  9. Urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Aeu) [ Time Frame: 12 hours prior to dosing up to Day 9 ]
  10. Cumulative urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Cum Aeu) [ Time Frame: 12 hours prior to dosing up to Day 9 ]
  11. Percentage of BIIB074 dose excreted per sampling interval (%Feu) [ Time Frame: 12 hours prior to dosing up to Day 9 ]
  12. Cumulative percentage of BIIB074 dose excreted (Cum %Feu) [ Time Frame: 12 hours prior to dosing up to Day 9 ]
  13. Maximum observed concentration (Cmax) [ Time Frame: 2 hours post dose up to Day 9 ]
  14. Time to reach Cmax (Tmax) [ Time Frame: 2 hours post dose up to Day 9 ]
  15. Area under the concentration-time curve from time 0 to time of the last measurable drug concentration (AUC0-t) [ Time Frame: 2 hours post dose up to Day 9 ]
  16. Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) [ Time Frame: 2 hours post dose up to Day 9 ]
  17. Terminal elimination half-life (t1/2) [ Time Frame: 2 hours post dose up to Day 9 ]
  18. Apparent total body clearance (CL/F) [ Time Frame: 2 hours post dose up to Day 9 ]
  19. Apparent volume of distribution (Vd/F) [ Time Frame: 2 hours post dose up to Day 9 ]
  20. Renal clearance (CLR) [ Time Frame: 2 hours post dose up to Day 9 ]
  21. Metabolite-to-parent ratio at Cmax (MRCmax) [ Time Frame: 2 hours post dose up to Day 9 ]
  22. Metabolite-to-parent ratio in AUC (MRAUC) [ Time Frame: 2 hours post dose up to Day 9 ]

Secondary Outcome Measures :
  1. Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Day 9 ]
  2. Number of participants with clinically significant vital sign abnormalities [ Time Frame: Up to Day 9 ]
  3. Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities [ Time Frame: Up to Day 9 ]
  4. Number of participants with clinically significant laboratory assessment abnormalities [ Time Frame: Up to Day 9 ]
  5. Radioactivity profiles in plasma, urine and feces [ Time Frame: Up to Day 9 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751905


Locations
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United States, Wisconsin
Research Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02751905     History of Changes
Other Study ID Numbers: 802HV105
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms