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

Healthy Volunteers Clinical Trial

Official title:

Interventional, Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122692
• Other study ID #: 15820A
• Secondary ID: 2013-003597-27
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2014
• Last updated: June 18, 2014
• Start date: March 2014

Study information

• Verified date: June 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Lu AE58054 30 mg
Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally
• Lu AE58054 30 mg + itraconazole 200 mg
Lu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally
• Itraconazole
Itraconazole capsules, once daily, Day 12-13, orally

Locations

Country	Name	City	State
France	FR801	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)		Day 5 and Day 11	No
Primary	Maximum observed concentration (Cmax) of Lu AE58054		Day 5 and Day 11	No
Secondary	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	No
Secondary	Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR)		Day 5 and Day 11	No
Secondary	Plasma pharmacokinetic parameters for itraconazole: CTrough		Day 6 to Day 13	No
Secondary	Adverse events		Up to Day 18, including a safety follow-up	Yes
Secondary	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	Yes