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CompletedNCT02751905Updated Jun 16, 2016

Absorption, Metabolism, and Excretion Study of BIIB074

A Phase 1 interventional study of BIIB074 in Neuropathic Pain, sponsored by Biogen. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-16.

Sponsored by Biogen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Neuropathic Pain

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03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 6 is below the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility 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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    BIIB074

    Single oral dose on Day 1

    Drug: BIIB074

Interventions

  • DrugBIIB074

    Administered orally as specified in treatment arm

    Also known as: CNV1014802

06

What researchers measure

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

07

Study locations

1 site
  • Research Site
    Madison, Wisconsin 53704, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02751905
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Apr 26, 2016
Start date
Apr 2016
Primary completion
May 2016
Completion
May 2016
Last update
Jun 16, 2016

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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