NCT02122692

Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects

Interventional, Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Lu AE58054 30 mg	Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally
DRUG	Lu AE58054 30 mg + itraconazole 200 mg	Lu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally
DRUG	Itraconazole	Itraconazole capsules, once daily, Day 12-13, orally

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-06-01
• First posted: 2014-04-24
• Last updated: 2014-06-19

Locations

1 site across 1 country: France