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
2 other identifiers
interventional
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 23, 2014
CompletedFirst Posted
Study publicly available on registry
April 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedJune 19, 2014
June 1, 2014
3 months
April 23, 2014
June 18, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
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
Study Arms (1)
Lu AE58054 30 mg + itraconazole 200 mg
EXPERIMENTALInterventions
Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally
Lu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally
Itraconazole capsules, once daily, Day 12-13, orally
Eligibility Criteria
You may qualify if:
- 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)) .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
FR801
Rennes, 35042, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2014
First Posted
April 24, 2014
Study Start
March 1, 2014
Primary Completion
June 1, 2014
Last Updated
June 19, 2014
Record last verified: 2014-06