Neuropathic PainPhase 1NCT02751905
Absorption, Metabolism, and Excretion Study of BIIB074
A Phase 1 study testing BIIB074 in people with Neuropathic Pain, run by Biogen at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- BIIB074
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Neuropathic Pain
- Being tested
- BIIB074
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB074Drug
Also called CNV1014802
Administered orally as specified in treatment arm
| Study group | Role | What they receive |
|---|---|---|
| BIIB074 | Experimental | Single oral dose on Day 1 Receives: Drug: BIIB074 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary amount excreted per sampling interval (Aeu)
Measured: 12 hours prior to dosing up to Day 9
Fecal amount excreted per sampling interval (Aef)
Measured: Prior to dosing up to Day 9
Cumulative urinary amount excreted per sampling interval (Cum Aeu)
Measured: 12 hours prior to dosing up to Day 9
Cumulative fecal amount excreted per sampling interval (Cum Aef)
Measured: Prior to dosing up to Day 9
Percentage of radioactive urinary dose excreted per sampling interval (%Feu)
Measured: 12 hours prior to dosing up to Day 9
Percentage of radioactive fecal dose excreted per sampling interval (%Fef)
Measured: Prior to dosing up to Day 9
Cumulative percentage of radioactive urinary dose excreted per sampling interval (Cum %Feu)
Measured: 12 hours prior to dosing up to Day 9
Cumulative percentage of radioactive fecal dose excreted per sampling interval (Cum %Fef)
Measured: Prior to dosing up to Day 9
Urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Aeu)
Measured: 12 hours prior to dosing up to Day 9
Cumulative urinary amount of BIIB074 and its known metabolites excreted per sampling interval (Cum Aeu)
Measured: 12 hours prior to dosing up to Day 9
Percentage of BIIB074 dose excreted per sampling interval (%Feu)
Measured: 12 hours prior to dosing up to Day 9
Cumulative percentage of BIIB074 dose excreted (Cum %Feu)
Measured: 12 hours prior to dosing up to Day 9
Maximum observed concentration (Cmax)
Measured: 2 hours post dose up to Day 9
Time to reach Cmax (Tmax)
Measured: 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)
Measured: 2 hours post dose up to Day 9
Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)
Measured: 2 hours post dose up to Day 9
Terminal elimination half-life (t1/2)
Measured: 2 hours post dose up to Day 9
Apparent total body clearance (CL/F)
Measured: 2 hours post dose up to Day 9
Apparent volume of distribution (Vd/F)
Measured: 2 hours post dose up to Day 9
Renal clearance (CLR)
Measured: 2 hours post dose up to Day 9
Metabolite-to-parent ratio at Cmax (MRCmax)
Measured: 2 hours post dose up to Day 9
Metabolite-to-parent ratio in AUC (MRAUC)
Measured: 2 hours post dose up to Day 9
Secondary outcomes (5)
Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to Day 9
Number of participants with clinically significant vital sign abnormalities
Measured: Up to Day 9
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Measured: Up to Day 9
Number of participants with clinically significant laboratory assessment abnormalities
Measured: Up to Day 9
Radioactivity profiles in plasma, urine and feces
Measured: Up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751905
- Sponsor's protocol ID
- 802HV105
- Status last verified
- Jun 2016
- First submitted
- 22 Apr 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-BIIB074 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02751905
- Acronym / sponsor ID
- 802HV105
- Conditions
- Neuropathic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIIB074 | Experimental | Drug: BIIB074Single oral dose on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIIB074Also: CNV1014802Administered orally as specified in treatment arm | Drug | BIIB074 |
Primary outcome
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
5 secondary outcomes
Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 9
Number of participants with clinically significant vital sign abnormalities
Time frame: Up to Day 9
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Up to Day 9
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: Up to Day 9
Radioactivity profiles in plasma, urine and feces
Time frame: Up to Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB074 in people with Neuropathic Pain, run by Biogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary amount excreted per sampling interval (Aeu) (time frame: 12 hours prior to dosing up to Day 9). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.