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.

Phase 1CompletedNCT02199431

H. Lundbeck A/S20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Lu AF11167DRUG

ItraconazoleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. Other pre-defined inclusion and exclusion criteria may apply.

Locations (1)

Covance

Leeds, United Kingdom

Outcomes

Primary Outcomes

Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf)

Time frame: Day 1 and 8

Maximum observed plasma concentration (Cmax) of Lu AF11167

Time frame: Day 1 and 8

Secondary Outcomes

Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf)

Time frame: Day 1 and 8

Maximum observed plasma concentration (Cmax) of Lu AF36201

Time frame: Day 1 and 8

Data from ClinicalTrials.gov

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