A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function

NCT04942964 | Completed Phase 1 FDA Drug

• 1 other identifier: 0367-CL-1102
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatic Impairment; Healthy Volunteers

Keywords

Mild and moderate hepatic impairment; Liver function; ASP0367; Pharmacokinetics; MA-0211; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK) of ASP0367 in Plasma: Area Under The Concentration-time Curve From Time of Dosing Extrapolated to Time Infinity (AUCinf)

  AUCinf will be recorded from the PK plasma samples collected.

  Up to 5 days

• Pharmacokinetics (PK) of ASP0367 in Plasma: Area Under Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast)

  AUClast will be recorded from the PK plasma samples collected.

  Up to 5 days

• Pharmacokinetics (PK) of ASP0367 in Plasma: Maximum Concentration (Cmax)

  Cmax will be recorded from the PK plasma samples collected.

  Up to 5 days

Secondary Outcomes (4)

• 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

Study Arms (3)

ASP0367: Mild Hepatic Impairment

EXPERIMENTAL

Participants with mild hepatic impairment will receive a single dose of ASP0367 under fasting conditions on day 1.

Drug: Bocidelpar

ASP0367: Moderate Hepatic Impairment

EXPERIMENTAL

Participants with moderate hepatic impairment will receive a single dose of ASP0367 under fasting conditions on day 1.

Drug: Bocidelpar

ASP0367: Normal Hepatic Function

EXPERIMENTAL

Participants with normal hepatic function will receive a single dose of ASP0367 under fasting conditions on day 1.

Drug: Bocidelpar

Interventions

Bocidelpar DRUG

Oral

Also known as: MA-0211, ASP0367

ASP0367: Mild Hepatic Impairment; ASP0367: Moderate Hepatic Impairment; ASP0367: Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Additional Criteria for Participants with Hepatic Impairment:
• Participant has mild (Child-Pugh classification Class A, score 5 or 6) or moderate (Child-Pugh classification Class B, score 7 to 9) hepatic impairment at screening

You may not qualify if:

• Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to day -1.
• 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 ASP0367.
• Participant has used moderate or strong inducers of CYP3A within the 3 months prior to day -1.
• 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.
• Participant has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to IP administration.
• Participant has/had febrile illness or symptomatic, viral (excluding chronic hepatitis B virus and hepatitis C virus), bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
• Participant has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
• Participant is an employee of Astellas, the study-related CROs or the clinical unit.
• Participant has a positive result for SARS-CoV-2 test at screening.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (3)

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

Orlando Clinical Research Center, Inc

Orlando, Florida, 32809, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: September 13, 2021
• Primary Completion: January 11, 2022
• Study Completion: January 20, 2022
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)