A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People

NCT05117294 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0367-CL-11112021-004042-38
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

Brief Summary

This study is for adults whose kidneys do not work well (renal impairment) and adults whose kidneys work normally. This study will provide more information on a potential new treatment, called ASP0367. The main aim of the study is to learn how ASP0367 is processed by the body in these different groups of people. This study will be in 2 parts. Part 2 will only happen if the results between the 2 groups are different in Part 1. In each part, people in the study will stay in a research unit for 6 days and 5 nights. Later, they will return to the research unit for 1 check-up. In Part 1, people whose kidneys work normally and people whose kidneys work very poorly (severe renal impairment) can take part. If Part 2 happens, people whose kidneys work normally and people whose kidneys do not work well (mild or moderate renal impairment) can take part. In both parts of the study, people who can take part will be admitted to the research unit. The next day they will take tablets of ASP0367 just once. People will give blood and urine samples at various times during their stay. They will have their vital signs (heart rate and blood pressure) checked regularly. People will also have ECGs to check their heart rhythm. They will be asked if they have any medical problems. After 6 days, provided all the checks have been done and there are no medical problems, people in the study will leave the research unit. People will return to the research unit for 1 check-up. This will be between 9 and 11 days after their last blood sample was taken during their previous stay in the unit. The check-up will include a physical exam, a check of people's vital signs (heart rate and blood pressure), and blood tests. Also, people will have an ECG and be asked if they have had any medical problems.

Conditions

Renal Impairment; Healthy Volunteers

Keywords

Severe renal impairment; Moderate renal impairment; Mild renal impairment; ASP0367; Pharmacokinetics; Healthy Volunteers; MA-0211; Kidney function; Bocidelpar

Outcome Measures

Primary Outcomes (4)

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

  AUCinf will be recorded from PK plasma samples collected.

  Up to 5 days

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

  AUClast will be recorded from PK plasma samples collected.

  Up to 5 days

• Pharmacokinetics (PK) of Bocidelpar (ASP0367) in Plasma: maximum concentration (Cmax)

  Cmax will be recorded from PK plasma samples collected.

  Up to 5 days

• Pharmacokinetics (PK) of Bocidelpar (ASP0367) in Plasma: apparent clearance (CL/F)

  CL/F will be recorded from 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 (4)

Bocidelpar (ASP0367): Severe Renal Impairment

EXPERIMENTAL

Participants with severe renal impairment will receive a single dose of Bocidelpar (ASP0367) under fasting conditions on day 1.

Drug: Bocidelpar

Bocidelpar (ASP0367): Moderate Renal Impairment

EXPERIMENTAL

Participants with moderate renal impairment will receive a single dose of Bocidelpar (ASP0367) under fasting conditions on day 1.

Drug: Bocidelpar

Bocidelpar (ASP0367): Mild Renal Impairment

EXPERIMENTAL

Participants with mild renal impairment will receive a single dose of Bocidelpar (ASP0367) under fasting conditions on day 1.

Drug: Bocidelpar

Bocidelpar (ASP0367): Normal Renal Function

EXPERIMENTAL

Participants with normal renal function will receive a single dose of Bocidelpar (ASP0367) under fasting conditions on day 1.

Drug: Bocidelpar

Interventions

Bocidelpar DRUG

Oral

Also known as: MA-0211, ASP0367

Bocidelpar (ASP0367): Mild Renal Impairment; Bocidelpar (ASP0367): Moderate Renal Impairment; Bocidelpar (ASP0367): Normal Renal Function; Bocidelpar (ASP0367): Severe Renal Impairment

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 body mass index range of 18.5 to 40.0 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 child-bearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 28 days after Investigational Product (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 first 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) must agree to use contraception throughout the treatment period and for 28 days after IP administration.
• Male participant must not donate sperm during the treatment 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.
• Participant has normal renal function as defined by estimated glomerular filtration rate (eGFR) using Modification of Diet in Renal Disease formula ≥ 90 mL/min per 1.73 m\^2 or participant has varying degrees of chronic kidney disease as defined by the National Kidney Foundation and by eGFR:
• to \< 90 mL/min per 1.73 m\^2 for participants with mild renal impairment
• to \< 60 mL/min per 1.73 m\^2 for participants with moderate renal impairment
• \< 30 mL/min per 1.73 m\^2 and not on hemodialysis, with approximately 50 percent of participants to have eGFR ≤ 20 mL/min per 1.73 m\^2 for participants with severe renal impairment
• Participant has adequate venous access.

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 any condition, which makes the participant unsuitable for study participation.
• Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
• Participant has a known or suspected hypersensitivity to ASP0367 or any components of the formulation used.
• Participant has had previous exposure with ASP0367.
• Participant has used moderate or strong inducers of Cytochrome P450 (CYP) 3A within the 3 months prior to day -1.
• Participant has used a strong CYP3A inhibitor within 5 half lives, prior to day -1.
• Participant has used proton pump inhibitor 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, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
• Participant has any of the liver function tests (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and total bilirubin ≥ 1.5 × upper limit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.
• 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 contract research organization (CRO) or the clinical unit.
• Participant has a positive result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) test at screening.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (4)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Inland Empire

Rialto, California, 92377, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Executive 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: November 1, 2021
• First Posted: November 11, 2021
• Study Start: December 21, 2021
• Primary Completion: November 13, 2022
• Study Completion: November 22, 2022
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)