A Phase 1 Open-label Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP0367 Compared to Participants With Normal Hepatic Function
Overview
- Phase
- Phase 1
- Intervention
- Bocidelpar
- Conditions
- Hepatic Impairment
- Sponsor
- Astellas Pharma Global Development, Inc.
- Enrollment
- 25
- Locations
- 3
- Primary Endpoint
- Pharmacokinetics (PK) of ASP0367 in Plasma: Area Under The Concentration-time Curve From Time of Dosing Extrapolated to Time Infinity (AUCinf)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to evaluate the effect of ASP0367 in participants with mild and moderate hepatic impairment compared to healthy participants with normal hepatic function. The study will also evaluate the safety and tolerability of ASP0367 in participants with mild and moderate hepatic impairment compared to healthy participants with normal hepatic function.
Detailed Description
The study will comprise of three groups based on hepatic function. Participants will be screened for up to 28 days prior to investigational product (IP) administration on Day 1. Eligible participants will be admitted to the clinical unit on Day -1 and will be residential for a single period of six days/five nights. On Day 1, participants will receive a single oral dose of ASP0367 under fasting conditions followed by a 96-hour in-house blood and urine sampling period. Participants are to remain semirecumbent for four hours postdose. Standard safety and tolerability assessments will be conducted. Participants will be discharged from the clinical unit on Day 5 on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit. The study will be completed with an end-of-study visit (ESV). The ESV will take place five to nine days after the last pharmacokinetic sample is collected or at the time of early discontinuation from the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant has a BMI range of 18.5 to 36.0 kg/m\^2, inclusive and weighs at least 50 kg at screening.
- •Female participant is not pregnant and at least 1 of the following conditions apply:
- •Not a woman of childbearing potential (WOCBP)
- •WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 28 days after IP administration.
- •Female participant must agree not to breastfeed starting at screening and throughout the study period and for 28 days after IP administration.
- •Female participant must not donate ova starting at dose of IP and throughout the study period and for 28 days after IP administration.
- •Male participant with female partner(s) of childbearing potential (including breastfeeding partner\[s\]) must agree to use contraception throughout the study period and for 28 days after IP administration.
- •Male participant must not donate sperm during the study period and for 28 days after IP administration.
- •Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 28 days after IP administration.
- •Participant agrees not to participate in another interventional study while participating in the present study.
Exclusion Criteria
- •Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to day -
- •Participant has had a partial hepatectomy within 1 year prior to screening.
- •Participant has any condition which makes the participant unsuitable for study participation.
- •Participant has a known or suspected hypersensitivity to ASP0367 or any components of the formulation used.
- •Participant has received a COVID-19 vaccine within the 2 weeks prior to IP administration or will have a COVID-19 vaccine dose before the ESV.
- •Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
- •Participant has had previous exposure with ASP
- •Participant has used moderate or strong inducers of CYP3A within the 3 months prior to day -
- •Participant has used proton-pump inhibitors within the 2 weeks prior to IP administration.
- •Participant has used Histamine-2 blockers within 24 hours prior to IP administration.
Arms & Interventions
ASP0367: Mild Hepatic Impairment
Participants with mild hepatic impairment will receive a single dose of ASP0367 under fasting conditions on day 1.
Intervention: Bocidelpar
ASP0367: Moderate Hepatic Impairment
Participants with moderate hepatic impairment will receive a single dose of ASP0367 under fasting conditions on day 1.
Intervention: Bocidelpar
ASP0367: Normal Hepatic Function
Participants with normal hepatic function will receive a single dose of ASP0367 under fasting conditions on day 1.
Intervention: Bocidelpar
Outcomes
Primary Outcomes
Pharmacokinetics (PK) of ASP0367 in Plasma: Area Under The Concentration-time Curve From Time of Dosing Extrapolated to Time Infinity (AUCinf)
Time Frame: Up to 5 days
AUCinf will be recorded from the PK plasma samples collected.
Pharmacokinetics (PK) of ASP0367 in Plasma: Area Under Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast)
Time Frame: Up to 5 days
AUClast will be recorded from the PK plasma samples collected.
Pharmacokinetics (PK) of ASP0367 in Plasma: Maximum Concentration (Cmax)
Time Frame: Up to 5 days
Cmax will be recorded from the PK plasma samples collected.
Secondary Outcomes
- Number of Participants with Adverse Events (AEs)(Up to Day 16)
- Number of Participants with Laboratory Value Abnormalities and/or AEs(Up to Day 16)
- Number of Participants with Vital Sign Abnormalities and/or AEs(Up to Day 16)
- Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or AEs(Up to Day 16)