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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Cytochrome P450 Interaction

Treatments: Drug: Itraconazole (200 mg); Drug: Lu AF35700; Drug: Itraconazole (300 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03103646

17208A

2016-003302-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups

Lu AF35700

Experimental group

Description:

Day 1: Single dose of Lu AF35700. Extensive metabolisers (EMs): 10mg. Poor metabolisers (PMs): 5 mg

Treatment:

Drug: Lu AF35700

Lu AF35700 AND itraconazole

Experimental group

Description:

Days 29 to 31: once-daily dosage of 200 mg itraconazole. Day 32: Single dose of Lu AF35700 (EMs: 10 mg, PMs: 5 mg) and 300 mg itraconazole Days 33 to 42: once-daily dosage of 200 mg itraconazole

Treatment:

Drug: Lu AF35700

Drug: Itraconazole (300 mg)

Drug: Itraconazole (200 mg)