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NCT02199431 Clinical Trial

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.

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02199431
Other study ID # 14380A
Secondary ID 2013-003870-28
Status Completed
Phase Phase 1
First received July 23, 2014
Last updated September 18, 2015
Start date July 2014

Study information
Verified date September 2015
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lu AF11167

• Itraconazole

Locations
Country Name City State
United Kingdom Covance Leeds

Sponsors (1)
Lead Sponsor Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf) Day 1 and 8 No
Primary Maximum observed plasma concentration (Cmax) of Lu AF11167 Day 1 and 8 No
Secondary Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf) Day 1 and 8 No
Secondary Maximum observed plasma concentration (Cmax) of Lu AF36201 Day 1 and 8 No
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