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Absorption, Metabolism, and Excretion Study of BIIB074

Primary Purpose

Neuropathic Pain

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BIIB074

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIIB074

Arm Description

Single oral dose on Day 1

Outcomes

Primary Outcome Measures

Urinary amount excreted per sampling interval (Aeu)

Fecal amount excreted per sampling interval (Aef)

Cumulative urinary amount excreted per sampling interval (Cum Aeu)

Cumulative fecal amount excreted per sampling interval (Cum Aef)

Percentage of radioactive urinary dose excreted per sampling interval (%Feu)

Percentage of radioactive fecal dose excreted per sampling interval (%Fef)

Cumulative percentage of radioactive urinary dose excreted per sampling interval (Cum %Feu)

Cumulative percentage of radioactive fecal dose excreted per sampling interval (Cum %Fef)

Urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Aeu)

Cumulative urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Cum Aeu)

Percentage of BIIB074 dose excreted per sampling interval (%Feu)

Cumulative percentage of BIIB074 dose excreted (Cum %Feu)

Maximum observed concentration (Cmax)

Time to reach Cmax (Tmax)

Area under the concentration-time curve from time 0 to time of the last measurable drug concentration (AUC0-t)

Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)

Terminal elimination half-life (t1/2)

Apparent total body clearance (CL/F)

Apparent volume of distribution (Vd/F)

Renal clearance (CLR)

Metabolite-to-parent ratio at Cmax (MRCmax)

Metabolite-to-parent ratio in AUC (MRAUC)

Secondary Outcome Measures

Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)

Number of participants with clinically significant vital sign abnormalities

Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

Number of participants with clinically significant laboratory assessment abnormalities

Radioactivity profiles in plasma, urine and feces

Full Information

NCT ID

NCT02751905

First Posted

April 22, 2016

Last Updated

June 15, 2016

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT02751905

Brief Title

Absorption, Metabolism, and Excretion Study of BIIB074

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIIB074

Arm Type

Experimental

Arm Description

Single oral dose on Day 1

Intervention Type

Drug

Intervention Name(s)

BIIB074

Other Intervention Name(s)

CNV1014802

Intervention Description

Administered orally as specified in treatment arm

Primary Outcome Measure Information:

Title

Urinary amount excreted per sampling interval (Aeu)

Time Frame

12 hours prior to dosing up to Day 9

Title

Fecal amount excreted per sampling interval (Aef)

Time Frame

Prior to dosing up to Day 9

Title

Cumulative urinary amount excreted per sampling interval (Cum Aeu)

Time Frame

12 hours prior to dosing up to Day 9

Title

Cumulative fecal amount excreted per sampling interval (Cum Aef)

Time Frame

Prior to dosing up to Day 9

Title

Percentage of radioactive urinary dose excreted per sampling interval (%Feu)

Time Frame

12 hours prior to dosing up to Day 9

Title

Percentage of radioactive fecal dose excreted per sampling interval (%Fef)

Time Frame

Prior to dosing up to Day 9

Title

Cumulative percentage of radioactive urinary dose excreted per sampling interval (Cum %Feu)

Time Frame

12 hours prior to dosing up to Day 9

Title

Cumulative percentage of radioactive fecal dose excreted per sampling interval (Cum %Fef)

Time Frame

Prior to dosing up to Day 9

Title

Urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Aeu)

Time Frame

12 hours prior to dosing up to Day 9

Title

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

Title

Percentage of BIIB074 dose excreted per sampling interval (%Feu)

Time Frame

12 hours prior to dosing up to Day 9

Title

Cumulative percentage of BIIB074 dose excreted (Cum %Feu)

Time Frame

12 hours prior to dosing up to Day 9

Title

Maximum observed concentration (Cmax)

Time Frame

2 hours post dose up to Day 9

Title

Time to reach Cmax (Tmax)

Time Frame

2 hours post dose up to Day 9

Title

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

Title

Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)

Time Frame

2 hours post dose up to Day 9

Title

Terminal elimination half-life (t1/2)

Time Frame

2 hours post dose up to Day 9

Title

Apparent total body clearance (CL/F)

Time Frame

2 hours post dose up to Day 9

Title

Apparent volume of distribution (Vd/F)

Time Frame

2 hours post dose up to Day 9

Title

Renal clearance (CLR)

Time Frame

2 hours post dose up to Day 9

Title

Metabolite-to-parent ratio at Cmax (MRCmax)

Time Frame

2 hours post dose up to Day 9

Title

Metabolite-to-parent ratio in AUC (MRAUC)

Time Frame

2 hours post dose up to Day 9

Secondary Outcome Measure Information:

Title

Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)

Time Frame

Up to Day 9

Title

Number of participants with clinically significant vital sign abnormalities

Time Frame

Up to Day 9

Title

Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

Time Frame

Up to Day 9

Title

Number of participants with clinically significant laboratory assessment abnormalities

Time Frame

Up to Day 9

Title

Radioactivity profiles in plasma, urine and feces

Time Frame

Up to Day 9

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53704

Country

United States

12. IPD Sharing Statement

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Absorption, Metabolism, and Excretion Study of BIIB074

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