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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Lu AE58054 30 mg; Drug: Lu AE58054 30 mg + itraconazole 200 mg; Drug: Itraconazole

• Registration Number: NCT02122692
• Lead Sponsor: H. Lundbeck A/S

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-24
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Subjects are eligible for inclusion into the study if they meet each of the following criteria:

• Men and women, aged 18 - 45 years.
• Body weight at least 50 kg and Body Mass index 19 - 28 kg/m2.
• Good general health ascertained by a detailed medical history, laboratory tests and physical examination.
• Non-childbearing potential or use of contraception (both sexes).
• Women must not be pregnant or lactating.
• Known CYP2D6 genotype (Extensive metaboliser (n=15) and poor metaboliser (n =5)) .

Other Inclusion and Exclusion Criteria may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lu AE58054 30 mg + itraconazole 200 mg	Lu AE58054 30 mg	-
Lu AE58054 30 mg + itraconazole 200 mg	Lu AE58054 30 mg + itraconazole 200 mg	-
Lu AE58054 30 mg + itraconazole 200 mg	Itraconazole	-

Primary Outcome Measures

Name	Time	Method
Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)	Day 5 and Day 11
Maximum observed concentration (Cmax) of Lu AE58054	Day 5 and Day 11

Secondary Outcome Measures

Name	Time	Method
Plasma pharmacokinetics for Lu AE58054: AUC0-24, Cmax, time at which maximum observed plasma concentration occurred (tmax), apparent oral clearance (CL/F), half life (t½) and apparent volume of distribution Vz/F	Day 5 and Day 11
Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR)	Day 5 and Day 11
Plasma pharmacokinetic parameters for itraconazole: CTrough	Day 6 to Day 13
Adverse events	Up to Day 18, including a safety follow-up
Columbia Suicide Severity Rating Scale (C-SSRS) categorization based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions	Up to Day 18, including a safety follow-up

Trial Locations

Locations (1)

FR801; 🇫🇷 Rennes, France