Trials / Completed
CompletedNCT02199431
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lu AF11167 | |
| DRUG | Itraconazole |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2015-02-01
- First posted
- 2014-07-24
- Last updated
- 2015-09-21
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02199431. Inclusion in this directory is not an endorsement.