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OpenTrials
Completed

NCT Number: NCT02199431

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.

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AF11167

Drug

Itraconazole

Drug

Primary outcomes

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

    Time frame: Day 1 and 8

  2. Maximum observed plasma concentration (Cmax) of Lu AF11167

    Time frame: Day 1 and 8

Secondary outcomes

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

    Time frame: Day 1 and 8

  2. Maximum observed plasma concentration (Cmax) of Lu AF36201

    Time frame: Day 1 and 8

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
First posted
Jul 24, 2014
Registry last updated
Sep 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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