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Completed

NCT Number: NCT02055703

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

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WCT Early Development

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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
  • 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.
  • Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
  • Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing

Treatment and study plan

E2609

Drug

Itraconazole

Drug

Rifampin

Drug

Digoxin

Drug

Donepezil

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 5, 2014
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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