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Trial record 91 of 79742 for:    subjects

A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil

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ClinicalTrials.gov Identifier: NCT02055703
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
This study will be a single-center, open-label, drug-drug interaction study in healthy male and female subjects. The study will consist of 3 parts: A, B, and C. In Part A, the effect of itraconazole or rifampin on the pharmacokinetics (PK) of E2609 and metabolites will be assessed. Approximately 32 subjects will be assigned to 1 of 2 treatment groups (itraconazole or rifampin) in equal numbers, with approximately 16 subjects per group. In Part B, the effects of steady-state dosing of E2609 on the PK of digoxin will be assessed in approximately 18 subjects. In Part C, the effects of donepezil administered in combination with, or 2 hours after, E2609 dosing on the PK of E2609 and metabolites, will be assessed in approximately 24 subjects.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: E2609 Drug: itraconazole Drug: rifampin Drug: digoxin Drug: donepezil Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: E2609
Experimental drug for Parts A, B, and C
Drug: itraconazole
Drug: rifampin
Drug: digoxin
Drug: donepezil
Active Comparator: itraconazole
Comparator drug for Part A1
Drug: E2609
Active Comparator: rifampin
Comparator drug for Part A2
Drug: E2609
Active Comparator: digoxin
Comparator drug for Part B
Drug: E2609
Active Comparator: donepezil
Comparator drug for Part C
Drug: E2609



Primary Outcome Measures :
  1. To evaluate the pharmacokinetics (PK) of single oral doses of E2609 and metabolites in subjects dosed alone or in combination with either rifampin or itraconazole [ Time Frame: Up to 48 days (Part A) ]
    Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.

  2. To evaluate the PK of single oral doses of digoxin in subjects dosed alone or in combination with E2609 [ Time Frame: Up to 48 days (Part B) ]
    Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.

  3. To evaluate the PK of single oral doses of E2609 and metabolites in subjects dosed alone, in combination with donepezil, or 2 hours before donepezil dosing [ Time Frame: Up to 86 day (Part C) ]
    Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.


Secondary Outcome Measures :
  1. Safety and tolerability of single oral doses of E2609 in subjects in the presence and absence of rifampin, itraconazole, digoxin, or donepezil [ Time Frame: Up to 182 days ]
    Safety assessments include monitoring and recording all adverse events (AEs), regular measurement of vital signs, and the performance of physical examinations.

  2. To evaluate the effects of DNA sequence variants potentially involved in absorption, distribution and metabolism of E2609. [ Time Frame: Up to 182 days ]
    DNA samples will be collected, stored, and may be used to examine the role of genetic variability in other genes potentially involved in absorption, distribution, metabolism, and excretion.



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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

  1. Healthy male or female subjects aged 18-55 years inclusive at the time of informed consent
  2. Provide written informed consent
  3. Willing and able to comply with all aspects of the protocol

Exclusion Criteria

  1. Any history of seizures or epilepsy (not including a history of simple febrile seizures in childhood) or disturbance of consciousness likely to be due to seizures
  2. A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by the mean of triplicate electrocardiograms (ECGs), recorded at least 1 min apart, at Screening or Baseline Periods
  3. Evidence of clinically significant disease (eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments or subjects who have a congenital abnormality in metabolism within 4 weeks before dosing.
  4. Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
  5. Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing

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): NCT02055703


Locations
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United States, Texas
WCT Early Development
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Eisai Inc.

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02055703     History of Changes
Other Study ID Numbers: E2609-A001-003
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015

Keywords provided by Eisai Inc.:
Healthy Subjects

Additional relevant MeSH terms:
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Donepezil
Itraconazole
Rifampin
Digoxin
Hydroxyitraconazole
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers