NCT03103646

Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women

Interventional, Open-label, One-sequence Crossover Study Evaluating the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics, Safety and Tolerability of Lu AF35700 in Healthy Young Men and Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.

Conditions

• Cytochrome P450 Interaction

Interventions

Type	Name	Description
DRUG	Lu AF35700	Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg
DRUG	Itraconazole (200 mg)	100 mg Capsules for oral use, 200 mg/day. In a fed state
DRUG	Itraconazole (300 mg)	100mg Capsules for oral use, 300 mg/day. In a fasted state.

Timeline

• Start date: 2017-03-28
• Primary completion: 2019-04-14
• Completion: 2019-07-19
• First posted: 2017-04-06
• Last updated: 2019-10-02

Locations

2 sites across 2 countries: United States, United Kingdom