Effect of Itraconazole on the Pharmacokinetics of BIIB074

NCT ID: NCT02698267

Last Updated: 2016-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-04-30

Brief Summary

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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 \[M16\]).

Detailed Description

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Conditions

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Neuropathic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIIB074

Administered orally on Day 1 and Day 11

Group Type EXPERIMENTAL

BIIB074

Intervention Type DRUG

Administered as specified in the treatment arm

Itraconazole

Intervention Type DRUG

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

Interventions

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BIIB074

Administered as specified in the treatment arm

Intervention Type DRUG

Itraconazole

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

Intervention Type DRUG

Other Intervention Names

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CNV1014802 Sporanox, Onmel

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2015-005096-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

802HV104

Identifier Type: -

Identifier Source: org_study_id

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