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.

Interventional, Open-label, Interaction Study Investigating the Effects of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics and Safety and Tolerability of Lu AF11167 in Healthy Young Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02199431

Enrollment

Registered

2014-07-24

Start date

2014-07-31

Completion date

Unknown

Last updated

2015-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Lu AF11167, Interaction

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

Interventions

DRUGLu AF11167

DRUGItraconazole

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026