A Phase 1, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-BIIB074 in Healthy Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Urinary amount excreted per sampling interval (Aeu)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
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 BIIB
- •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.
Arms & Interventions
BIIB074
Single oral dose on Day 1
Intervention: BIIB074 (Drug)
Outcomes
Primary Outcomes
Urinary amount excreted per sampling interval (Aeu)
Time Frame: 12 hours prior to dosing up to Day 9
Fecal amount excreted per sampling interval (Aef)
Time Frame: Prior to dosing up to Day 9
Cumulative urinary amount excreted per sampling interval (Cum Aeu)
Time Frame: 12 hours prior to dosing up to Day 9
Cumulative fecal amount excreted per sampling interval (Cum Aef)
Time Frame: Prior to dosing up to Day 9
Percentage of radioactive urinary dose excreted per sampling interval (%Feu)
Time Frame: 12 hours prior to dosing up to Day 9
Percentage of radioactive fecal dose excreted per sampling interval (%Fef)
Time Frame: Prior to dosing up to Day 9
Cumulative percentage of radioactive urinary dose excreted per sampling interval (Cum %Feu)
Time Frame: 12 hours prior to dosing up to Day 9
Cumulative percentage of radioactive fecal dose excreted per sampling interval (Cum %Fef)
Time Frame: Prior to dosing up to Day 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
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
Percentage of BIIB074 dose excreted per sampling interval (%Feu)
Time Frame: 12 hours prior to dosing up to Day 9
Cumulative percentage of BIIB074 dose excreted (Cum %Feu)
Time Frame: 12 hours prior to dosing up to Day 9
Maximum observed concentration (Cmax)
Time Frame: 2 hours post dose up to Day 9
Time to reach Cmax (Tmax)
Time Frame: 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)
Time Frame: 2 hours post dose up to Day 9
Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Time Frame: 2 hours post dose up to Day 9
Terminal elimination half-life (t1/2)
Time Frame: 2 hours post dose up to Day 9
Apparent total body clearance (CL/F)
Time Frame: 2 hours post dose up to Day 9
Apparent volume of distribution (Vd/F)
Time Frame: 2 hours post dose up to Day 9
Renal clearance (CLR)
Time Frame: 2 hours post dose up to Day 9
Metabolite-to-parent ratio at Cmax (MRCmax)
Time Frame: 2 hours post dose up to Day 9
Metabolite-to-parent ratio in AUC (MRAUC)
Time Frame: 2 hours post dose up to Day 9
Secondary Outcomes
- 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)