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 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lu AF11167; Drug: Itraconazole

• Registration Number: NCT02199431
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-24
• Primary Completion: 2015-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-18
• Last Update Posted: 2015-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule	Lu AF11167	Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8
Lu AF1167 capsule 0.5 mg	Lu AF11167	Single oral dose (day 1)
Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule	Itraconazole	Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8

Primary Outcome Measures

Name	Time	Method
Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf)	Day 1 and 8
Maximum observed plasma concentration (Cmax) of Lu AF11167	Day 1 and 8

Secondary Outcome Measures

Name	Time	Method
Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf)	Day 1 and 8
Maximum observed plasma concentration (Cmax) of Lu AF36201	Day 1 and 8

Trial Locations

Locations (1)

Covance; 🇬🇧 Leeds, United Kingdom