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Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women

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ClinicalTrials.gov Identifier: NCT03103646
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.

Condition or disease Intervention/treatment Phase
Cytochrome P450 Interaction Drug: Lu AF35700 Drug: Itraconazole (200 mg) Drug: Itraconazole (300 mg) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Open-label, One-sequence Crossover Study Evaluating the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics, Safety and Tolerability of Lu AF35700 in Healthy Young Men and Women
Actual Study Start Date : March 28, 2017
Actual Primary Completion Date : April 14, 2019
Actual Study Completion Date : July 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lu AF35700
Day 1: Single dose of Lu AF35700. Extensive metabolisers (EMs): 10mg. Poor metabolisers (PMs): 5 mg
Drug: Lu AF35700
Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg

Experimental: Lu AF35700 AND itraconazole
Days 29 to 31: once-daily dosage of 200 mg itraconazole. Day 32: Single dose of Lu AF35700 (EMs: 10 mg, PMs: 5 mg) and 300 mg itraconazole Days 33 to 42: once-daily dosage of 200 mg itraconazole
Drug: Lu AF35700
Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg

Drug: Itraconazole (200 mg)
100 mg Capsules for oral use, 200 mg/day. In a fed state

Drug: Itraconazole (300 mg)
100mg Capsules for oral use, 300 mg/day. In a fasted state.




Primary Outcome Measures :
  1. AUC(0-inf) [ Time Frame: Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose ]
    Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs

  2. Cmax [ Time Frame: 0-24 hours postdose (Day 1 and day 32) ]
    Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs



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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:

  • Men, aged ≥18 and ≤55 years. body weight ≥50 kg
  • women, aged ≥18 and ≤45 years, body weight ≥50 kg
  • Good general health as assessed using detailed medical history, laboratory tests, and physical examination
  • Known CYP2D6 and CYP2C19 genotype

Exclusion Criteria:

  • Pregnant or lactating
  • Subject has previously been dosed with Lu AF35700

Other protocol 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): NCT03103646


Locations
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United States, Texas
Covance - Dallas
Dallas, Texas, United States, 75247
United Kingdom
Covance Clinical Research Unit Ltd
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: NCT03103646     History of Changes
Other Study ID Numbers: 17208A
2016-003302-14 ( EudraCT Number )
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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