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Completed

NCT Number: NCT02751905

Absorption, Metabolism, and Excretion Study of BIIB074

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIIB074

Drug

Administered orally as specified in treatment arm

Other names: CNV1014802

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2016
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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