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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02122692

Enrollment

Registered

2014-04-24

Start date

2014-03-31

Completion date

Unknown

Last updated

2014-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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).

Interventions

DRUGLu AE58054 30 mg

Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally

DRUGLu 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

DRUGItraconazole

Itraconazole capsules, once daily, Day 12-13, orally

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Plasma pharmacokinetic parameters for itraconazole: CTrough	Day 6 to Day 13
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
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
Adverse events	Up to Day 18, including a safety follow-up
Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR)	Day 5 and Day 11

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026