An Open-Label Parallel-Group Study to Evaluate the Pharmacokinetics of E2609 and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared With Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 32
- Primary Endpoint
- Mean maximum plasma concentration (Cmax) of E2609
Study Overview
Brief Summary
The primary objective of the study is to evaluate the effects of hepatic impairment on the pharmacokinetics (PK) of E2609 after a single dose administration.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1
Participants with mild hepatic impairment (Child-Pugh class A).
Intervention: E2609 (Drug)
Cohort 1C
Healthy participants (control) matched to participants in Cohort 1.
Intervention: E2609 (Drug)
Cohort 2
Participants with moderate hepatic impairment (Child-Pugh class B)
Intervention: E2609 (Drug)
Cohort 2C
Healthy participants (control) matched to participants in Cohort 2
Intervention: E2609 (Drug)
Outcomes
Primary Outcomes
Mean maximum plasma concentration (Cmax) of E2609
Time Frame: Day 1 through 7
Blood samples for pharmacokinetic (PK) assessments will be collected on Day 1 (before dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after dosing), Day 2 (24 and 36 hours after dosing), Day 3 (48 hours after dosing), Day 4 (72 hours after dosing), Day 5 (96 hours after dosing), Day 6 (120 hours after dosing), and Day 7 (144 hours after dosing).
Mean area under plasma concentration versus time curve from time zero to time of last quantifiable concentration (AUC(0-t)) of E2609
Time Frame: Day 1 through 7
Blood samples for PK assessments will be collected on Day 1 (before dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after dosing), Day 2 (24 and 36 hours after dosing), Day 3 (48 hours after dosing), Day 4 (72 hours after dosing), Day 5 (96 hours after dosing), Day 6 (120 hours after dosing), and Day 7 (144 hours after dosing).
Mean area under plasma concentration versus time curve from time zero to infinity (AUC(0-inf)) of E2609
Time Frame: Day 1 through 7
Blood samples for PK assessments will be collected on Day 1 (before dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after dosing), Day 2 (24 and 36 hours after dosing), Day 3 (48 hours after dosing), Day 4 (72 hours after dosing), Day 5 (96 hours after dosing), Day 6 (120 hours after dosing), and Day 7 (144 hours after dosing).
Secondary Outcomes
- Mean AUC(0-inf) values adjusted by unbound fraction in plasma (AUCu) of E2609(Day 1 through 7)
- Mean Cmax values adjusted for unbound fraction in plasma (Cmaxu) of E2609(Day 1 through 7)
- Mean time to reach maximum plasma concentration (tmax) of E2609 and its metabolites(Day 1 through 7)
- Mean ratio of AUC(0-inf) of individual metabolite to AUC(0-inf) of E2609, corrected for molecular weight (AUC metabolite ratio)(Day 1 through 7)
- Number of participants with treatment emergent adverse events and serious adverse events(Up to approximately 36 weeks)
- Mean apparent volume of distribution (Vz/F) of E2609(Day 1 through 7)
- Mean Apparent clearance relative to the unbound plasma concentration based on AUCu (CLu/F) of E2609(Day 1 through 7)
- Mean terminal phase plasma half-life (t1/2) of E2609 and its metabolites(Day 1 through 7)
- Mean apparent total body clearance (CL/F) of E2609(Day 1 through 7)
- Mean plasma protein unbound fraction (fu) of E2609(Day 1 through 7)