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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02122692
Recruitment Status : Completed
First Posted : April 24, 2014
Last Update Posted : June 19, 2014
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE April 23, 2014
First Posted Date  ICMJE April 24, 2014
Last Update Posted Date June 19, 2014
Study Start Date  ICMJE March 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2014)
  • Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24) [ Time Frame: Day 5 and Day 11 ]
  • Maximum observed concentration (Cmax) of Lu AE58054 [ Time Frame: Day 5 and Day 11 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02122692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2014)
  • 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 [ Time Frame: Day 5 and Day 11 ]
  • Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR) [ Time Frame: Day 5 and Day 11 ]
  • Plasma pharmacokinetic parameters for itraconazole: CTrough [ Time Frame: Day 6 to Day 13 ]
  • Adverse events [ Time Frame: 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 [ Time Frame: Up to Day 18, including a safety follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Lu AE58054 30 mg
    Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally
  • Drug: 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
  • Drug: Itraconazole
    Itraconazole capsules, once daily, Day 12-13, orally
Study Arms  ICMJE Experimental: Lu AE58054 30 mg + itraconazole 200 mg
Interventions:
  • Drug: Lu AE58054 30 mg
  • Drug: Lu AE58054 30 mg + itraconazole 200 mg
  • Drug: Itraconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02122692
Other Study ID Numbers  ICMJE 15820A
2013-003597-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP