Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lu AF1167 capsule 0.5 mg

Single oral dose (day 1)

Group Type EXPERIMENTAL

Lu AF11167

Intervention Type DRUG

Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule

Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8

Group Type EXPERIMENTAL

Lu AF11167

Intervention Type DRUG

Itraconazole

Intervention Type DRUG

Interventions

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Lu AF11167

Intervention Type DRUG

Itraconazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects be 18 years of age and 55 years of age and with a BMI \>18.5 kg/m2 and \<30.0 kg/m2 at the Screening Visit. Women must not be pregnant or lactating.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes