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.

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Itraconazole; Drug: Lu AF11167

Study type: Interventional

Funder types: Industry

Identifiers

NCT02199431

2013-003870-28 (EudraCT Number)

14380A

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Lu AF1167 capsule 0.5 mg

Experimental group

Description:

Single oral dose (day 1)

Treatment:

Drug: Lu AF11167

Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule

Experimental group

Description:

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

Treatment:

Drug: Lu AF11167

Drug: Itraconazole