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Effect of Itraconazole on the Pharmacokinetics of BIIB074

NCT02698267 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-06-09

No results posted yet for this study

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 \[M16\]).

Conditions

  • Neuropathic Pain

Interventions

DRUG

BIIB074

Administered as specified in the treatment arm

DRUG

Itraconazole

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02698267 on ClinicalTrials.gov