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Trial record 92 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.

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ClinicalTrials.gov Identifier: NCT02199431
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers

Condition or disease Intervention/treatment Phase
Healthy Drug: Lu AF11167 Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Open-label, Interaction Study Investigating the Effects of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics and Safety and Tolerability of Lu AF11167 in Healthy Young Subjects
Study Start Date : July 2014
Actual Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Lu AF1167 capsule 0.5 mg
Single oral dose (day 1)
Drug: Lu AF11167
Experimental: Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule
Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8
Drug: Lu AF11167
Drug: Itraconazole



Primary Outcome Measures :
  1. Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf) [ Time Frame: Day 1 and 8 ]
  2. Maximum observed plasma concentration (Cmax) of Lu AF11167 [ Time Frame: Day 1 and 8 ]

Secondary Outcome Measures :
  1. Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf) [ Time Frame: Day 1 and 8 ]
  2. Maximum observed plasma concentration (Cmax) of Lu AF36201 [ Time Frame: Day 1 and 8 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects be 18 years of age and 55 years of age and with a BMI >18.5 kg/m2 and <30.0 kg/m2 at the Screening Visit. Women must not be pregnant or lactating.

Other pre-defined 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): NCT02199431


Locations
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United Kingdom
Covance
Leeds, United Kingdom
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: NCT02199431     History of Changes
Other Study ID Numbers: 14380A
2013-003870-28 ( EudraCT Number )
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: September 21, 2015
Last Verified: September 2015

Keywords provided by H. Lundbeck A/S:
Lu AF11167
Interaction

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