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

Phase 1

Completed

• Conditions: Cytochrome P450 Interaction
• Interventions: Drug: Lu AF35700; Drug: Itraconazole (200 mg); Drug: Itraconazole (300 mg)

• Registration Number: NCT03103646
• Lead Sponsor: H. Lundbeck A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-28
• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-06
• Primary Completion: 2019-04-14
• Study Completion: 2019-07-19
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lu AF35700 AND itraconazole	Itraconazole (300 mg)	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
Lu AF35700 AND itraconazole	Itraconazole (200 mg)	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
Lu AF35700	Lu AF35700	Day 1: Single dose of Lu AF35700. Extensive metabolisers (EMs): 10mg. Poor metabolisers (PMs): 5 mg
Lu AF35700 AND itraconazole	Lu AF35700	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

Primary Outcome Measures

Name	Time	Method
AUC(0-inf)	Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose	Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs
Cmax	0-24 hours postdose (Day 1 and day 32)	Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs

Trial Locations

Locations (2)

Covance Clinical Research Unit Ltd; 🇬🇧 Leeds, United Kingdom

Covance - Dallas; 🇺🇸 Dallas, Texas, United States