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

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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

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).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Lu AE58054 30 mg Drug: Lu AE58054 30 mg + itraconazole 200 mg Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2014
Actual Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lu AE58054 30 mg + itraconazole 200 mg 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




Primary Outcome Measures :
  1. 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 ]
  2. Maximum observed concentration (Cmax) of Lu AE58054 [ Time Frame: Day 5 and Day 11 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR) [ Time Frame: Day 5 and Day 11 ]
  3. Plasma pharmacokinetic parameters for itraconazole: CTrough [ Time Frame: Day 6 to Day 13 ]
  4. Adverse events [ Time Frame: Up to Day 18, including a safety follow-up ]
  5. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122692


Locations
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France
FR801
Rennes, France, 35042
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02122692     History of Changes
Other Study ID Numbers: 15820A
2013-003597-27 ( EudraCT Number )
First Posted: April 24, 2014    Key Record Dates
Last Update Posted: June 19, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors