Absorption, Metabolism, and Excretion Study of BIIB074

June 15, 2016 updated by: Biogen

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BIIB074
Single oral dose on Day 1
Drug: BIIB074
Administered orally as specified in treatment arm
Other Names:
  • CNV1014802

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Urinary amount excreted per sampling interval (Aeu)
Time Frame: 12 hours prior to dosing up to Day 9
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
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
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
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
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
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
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
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
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
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
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
12 hours prior to dosing up to Day 9
Maximum observed concentration (Cmax)
Time Frame: 2 hours post dose up to Day 9
2 hours post dose up to Day 9
Time to reach Cmax (Tmax)
Time Frame: 2 hours post dose up to Day 9
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
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
2 hours post dose up to Day 9
Terminal elimination half-life (t1/2)
Time Frame: 2 hours post dose up to Day 9
2 hours post dose up to Day 9
Apparent total body clearance (CL/F)
Time Frame: 2 hours post dose up to Day 9
2 hours post dose up to Day 9
Apparent volume of distribution (Vd/F)
Time Frame: 2 hours post dose up to Day 9
2 hours post dose up to Day 9
Renal clearance (CLR)
Time Frame: 2 hours post dose up to Day 9
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
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
2 hours post dose up to Day 9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to Day 9
Up to Day 9
Number of participants with clinically significant vital sign abnormalities
Time Frame: Up to Day 9
Up to Day 9
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time Frame: Up to Day 9
Up to Day 9
Number of participants with clinically significant laboratory assessment abnormalities
Time Frame: Up to Day 9
Up to Day 9
Radioactivity profiles in plasma, urine and feces
Time Frame: Up to Day 9
Up to Day 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 802HV105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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