Trial record 1 of 9 for:    Lu AE58054
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Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT02122692
First received: April 23, 2014
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Lu AE58054 30 mg
Drug: Lu AE58054 30 mg + itraconazole 200 mg
Drug: Itraconazole
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Maximum observed concentration (Cmax) of Lu AE58054 [ Time Frame: Day 5 and Day 11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR) [ Time Frame: Day 5 and Day 11 ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetic parameters for itraconazole: CTrough [ Time Frame: Day 6 to Day 13 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Up to Day 18, including a safety follow-up ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: March 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02122692

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

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02122692     History of Changes
Other Study ID Numbers: 15820A, 2013-003597-27
Study First Received: April 23, 2014
Last Updated: June 18, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Itraconazole
Hydroxyitraconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014