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

• Status: Completed
• Trial end date: 2019-07-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

Inclusion Criteria:

• Men, aged ≥18 and ≤55 years. body weight ≥50 kg

• women, aged ≥18 and ≤45 years, body weight ≥50 kg

• Good general health as assessed using detailed medical history, laboratory tests, and physical examination

• Known CYP2D6 and CYP2C19 genotype

Exclusion Criteria:

• Pregnant or lactating

• Subject has previously been dosed with Lu AF35700

Other protocol defined inclusion and exclusion criteria may apply