Healthy SubjectsPhase 1NCT02055703
A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil
A Phase 1 study testing E2609, itraconazole and rifampin in people with Healthy Subjects, run by Eisai Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- E2609, itraconazole and rifampin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Subjects
- Being tested
- E2609, itraconazole, rifampin, digoxin, donepezil
- Keywords
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2609Drug
itraconazoleDrug
rifampinDrug
digoxinDrug
donepezilDrug
| Study group | Role | What they receive |
|---|---|---|
| E2609 | Experimental | Experimental drug for Parts A, B, and C Receives: Drug: itraconazole; Drug: rifampin; Drug: digoxin; Drug: donepezil |
| itraconazole | Active comparator | Comparator drug for Part A1 Receives: Drug: E2609 |
| rifampin | Active comparator | Comparator drug for Part A2 Receives: Drug: E2609 |
| digoxin | Active comparator | Comparator drug for Part B Receives: Drug: E2609 |
| donepezil | Active comparator | Comparator drug for Part C Receives: Drug: E2609 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
Measured: Up to 48 days (Part A)
To evaluate the PK of single oral doses of digoxin in subjects dosed alone or in combination with E2609
Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
Measured: Up to 48 days (Part B)
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
Primary PK Parameters being measured: AUC(0-t), AUC(0-inf), Cmax, tmax.
Measured: Up to 86 day (Part C)
Secondary outcomes (2)
Safety and tolerability of single oral doses of E2609 in subjects in the presence and absence of rifampin, itraconazole, digoxin, or donepezil
Safety assessments include monitoring and recording all adverse events (AEs), regular measurement of vital signs, and the performance of physical examinations.
Measured: Up to 182 days
To evaluate the effects of DNA sequence variants potentially involved in absorption, distribution and metabolism of E2609.
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.
Measured: Up to 182 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055703
- Sponsor's protocol ID
- E2609-A001-003
- Status last verified
- Nov 2015
- First submitted
- 23 Jan 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil
- ClinicalTrials.gov ID
- NCT02055703
- Acronym / sponsor ID
- E2609-A001-003
- Conditions
- Healthy Subjects
- Keywords
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| E2609 | Experimental | Drug: itraconazole, Drug: rifampin, Drug: digoxin, Drug: donepezilExperimental drug for Parts A, B, and C |
| itraconazole | Active comparator | Drug: E2609Comparator drug for Part A1 |
| rifampin | Active comparator | Drug: E2609Comparator drug for Part A2 |
| digoxin | Active comparator | Drug: E2609Comparator drug for Part B |
| donepezil | Active comparator | Drug: E2609Comparator drug for Part C |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E2609 | Drug | digoxin, donepezil, itraconazole, rifampin |
| itraconazole | Drug | E2609 |
| rifampin | Drug | E2609 |
| digoxin | Drug | E2609 |
| donepezil | Drug | E2609 |
Primary outcome
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.
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.
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.
2 secondary outcomes
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
To evaluate the effects of DNA sequence variants potentially involved in absorption, distribution and metabolism of E2609.
Time frame: Up to 182 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E2609, itraconazole and rifampin in people with Healthy Subjects, run by Eisai Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.