NCT02698267

Brief 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 inhibition on the PK of 3 metabolites of BIIB074 (CNV3000497 \[M13\], CNV2283325 \[M14\], and CNV2288584 \[M16\]).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

February 29, 2016

Last Update Submit

June 7, 2016

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

  • Maximum observed concentration (Cmax) of BIIB074

    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)

    Prior to dosing up to 96 hours post dose

Secondary Outcomes (20)

  • Terminal elimination half-life (t1/2) of BIIB074

    96 hours post dose

  • Apparent total body clearance (CL/F) of BIIB074

    96 hours post dose

  • Apparent volume of distribution (Vd/F) of BIIB074

    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

    Prior to dosing up to 96 hours post dose

  • Time that the maximum observed concentration occurs (Tmax) of BIIB074

    Prior to dosing up to 96 hours post dose

  • +15 more secondary outcomes

Study Arms (1)

BIIB074

EXPERIMENTAL

Administered orally on Day 1 and Day 11

Drug: BIIB074Drug: Itraconazole

Interventions

BIIB074DRUG

Administered as specified in the treatment arm

Also known as: CNV1014802
BIIB074
ItraconazoleDRUG

200 mg twice daily \[BID\] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive

Also known as: Sporanox, Onmel
BIIB074

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Females of childbearing potential.
  • Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Neuralgia

Interventions

vixotrigineItraconazole

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 3, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 9, 2016

Record last verified: 2016-06

Locations

GB(1)