Neuropathic PainPhase 1NCT02698267
Effect of Itraconazole on the Pharmacokinetics of BIIB074
A Phase 1 study testing BIIB074 and Itraconazole in people with Neuropathic Pain, run by Biogen at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to assess the effect of cytochrome P450 (CYP) 3A4 inhibition on the pharmacokinetics (PK) of BIIB074. The secondary objectives of this study are to assess the safety and tolerability of BIIB074 when co-administered with a strong CYP3A4 inhibitor and to assess the effect of CYP3A4… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- BIIB074 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Apr 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of 18 to 29 kg/m2, inclusive, with body weight ≥50 kg for males and ≥45 kg for females.
- Male or postmenopausal or surgically sterile females.
- Must be in good health as determined by the Investigator (or designee), based on medical history and screening evaluations.
Who cannot join
- Females of childbearing potential.
- Other unspecified reasons that, in the opinion of the Investigator or Sponsor, 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: An Open-label, Fixed-sequence, Phase 1 Study of the Effect of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of BIIB074 in Healthy Subjects
The primary objective of the study is to assess the effect of cytochrome P450 (CYP) 3A4 inhibition on the pharmacokinetics (PK) of BIIB074. The secondary objectives of this study are to assess the safety and tolerability of BIIB074 when co-administered with a strong CYP3A4 inhibitor and to assess the effect of CYP3A4 inhibition on the PK of 3 metabolites of BIIB074 (CNV3000497 [M13], CNV2283325 [M14], and CNV2288584 [M16]).
- Conditions
- Neuropathic Pain
- Being tested
- BIIB074, Itraconazole
- 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 as specified in the treatment arm
ItraconazoleDrug
Also called Sporanox, Onmel
200 mg twice daily [BID] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive
| Study group | Role | What they receive |
|---|---|---|
| BIIB074 | Experimental | Administered orally on Day 1 and Day 11 Receives: Drug: BIIB074; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of BIIB074
Measured: Prior to dosing up to 96 hours post dose
Exposure of BIIB074 as measured by area under the concentration-time curve from time zero to infinity (AUCinf)
Measured: Prior to dosing up to 96 hours post dose
Secondary outcomes (20)
Terminal elimination half-life (t1/2) of BIIB074
Measured: 96 hours post dose
Apparent total body clearance (CL/F) of BIIB074
Measured: 96 hours post dose
Apparent volume of distribution (Vd/F) of BIIB074
Measured: 96 hours post dose
Area under the concentration-time curve from time zero to time of the last measurable drug concentration (AUC0-t) of BIIB074
Measured: Prior to dosing up to 96 hours post dose
Time that the maximum observed concentration occurs (Tmax) of BIIB074
Measured: Prior to dosing up to 96 hours post dose
Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 25 days
Number of participants with clinically significant vital sign abnormalities
Measured: Up to 25 days
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Measured: Up to 25 days
Number of participants with clinically significant laboratory assessment abnormalities
Measured: Up to 25 days
Effect of CYP3A4 inhibition on the Cmax of 3 metabolites of BIIB074
Measured: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the AUCinf of 3 metabolites of BIIB074
Measured: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the AUC0-t of CNV3000497 (M13)
Measured: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the AUC0-t of CNV2283325 (M14)
Measured: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the AUC0-t of CNV2288584 (M16)
Measured: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the Tmax of CNV3000497 (M13)
Measured: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the Tmax of CNV2283325 (M14)
Measured: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the Tmax of CNV2288584 (M16)
Measured: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the t1/2 of CNV3000497 (M13)
Measured: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the t1/2 of CNV2283325 (M14)
Measured: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the t1/2 of CNV2288584 (M16)
Measured: Prior to dosing up to 96 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2016
- Study completionApr 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
- 16 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
- NCT02698267
- Sponsor's protocol ID
- 802HV104
- Other IDs
- 2015-005096-25, 2015
- Status last verified
- Jun 2016
- First submitted
- 29 Feb 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-sequence, Phase 1 Study of the Effect of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of BIIB074 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02698267
- Acronym / sponsor ID
- 802HV104
- Conditions
- Neuropathic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Mar 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 objective of the study is to assess the effect of cytochrome P450 (CYP) 3A4 inhibition on the pharmacokinetics (PK) of BIIB074. The secondary objectives of this study are to assess the safety and tolerability of BIIB074 when co-administered with a strong CYP3A4 inhibitor and to assess the effect of CYP3A4 inhibition on the PK of 3 metabolites of BIIB074 (CNV3000497 [M13], CNV2283325 [M14], and CNV2288584 [M16]).
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: BIIB074, Drug: ItraconazoleAdministered orally on Day 1 and Day 11 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index of 18 to 29 kg/m2, inclusive, with body weight ≥50 kg for males and ≥45 kg for females.
- Male or postmenopausal or surgically sterile females.
- Must be in good health as determined by the Investigator (or designee), based on medical history and screening evaluations.
Key exclusion criteria (3 listed)
- Females of childbearing potential.
- Other unspecified reasons that, in the opinion of the Investigator or Sponsor, 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 as specified in the treatment arm | Drug | BIIB074 |
| ItraconazoleAlso: Sporanox, Onmel200 mg twice daily [BID] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive | Drug | BIIB074 |
Primary outcome
Maximum observed concentration (Cmax) of BIIB074
Time frame: Prior to dosing up to 96 hours post dose
Exposure of BIIB074 as measured by area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: Prior to dosing up to 96 hours post dose
20 secondary outcomes
Terminal elimination half-life (t1/2) of BIIB074
Time frame: 96 hours post dose
Apparent total body clearance (CL/F) of BIIB074
Time frame: 96 hours post dose
Apparent volume of distribution (Vd/F) of BIIB074
Time frame: 96 hours post dose
Area under the concentration-time curve from time zero to time of the last measurable drug concentration (AUC0-t) of BIIB074
Time frame: Prior to dosing up to 96 hours post dose
Time that the maximum observed concentration occurs (Tmax) of BIIB074
Time frame: Prior to dosing up to 96 hours post dose
Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 25 days
Number of participants with clinically significant vital sign abnormalities
Time frame: Up to 25 days
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Up to 25 days
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: Up to 25 days
Effect of CYP3A4 inhibition on the Cmax of 3 metabolites of BIIB074
Time frame: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the AUCinf of 3 metabolites of BIIB074
Time frame: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the AUC0-t of CNV3000497 (M13)
Time frame: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the AUC0-t of CNV2283325 (M14)
Time frame: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the AUC0-t of CNV2288584 (M16)
Time frame: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the Tmax of CNV3000497 (M13)
Time frame: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the Tmax of CNV2283325 (M14)
Time frame: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the Tmax of CNV2288584 (M16)
Time frame: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the t1/2 of CNV3000497 (M13)
Time frame: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the t1/2 of CNV2283325 (M14)
Time frame: Prior to dosing up to 96 hours post dose
Effect of CYP3A4 inhibition on the t1/2 of CNV2288584 (M16)
Time frame: Prior to dosing up to 96 hours post dose
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 9 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 and Itraconazole in people with Neuropathic Pain, run by Biogen at 1 site in United Kingdom.
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 3 inclusion and 3 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 9 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 Kingdom. 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?
Maximum observed concentration (Cmax) of BIIB074 (time frame: Prior to dosing up to 96 hours post dose). The study lists 2 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 9 Jun 2016.