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Hepatic ImpairmentPhase 1NCT04942964

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

A Phase 1 study testing Bocidelpar in people with Hepatic Impairment and Healthy Volunteers, run by Astellas Pharma Global Development, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment, Healthy Volunteers
What is being tested?
Bocidelpar
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
3 sitesUnited States
Study dates
13 Sep 2021to 20 Jan 2022
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.
  • Participant has creatinine level outside normal limits on day -1. In such a case, the assessment may be repeated once.
  • Additional Criteria for Participants with Hepatic Impairment:
  • Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy not related to current disease state.
  • Participant has cardiac troponin I (cTnI) > upper limit of normal (ULN) (or cardiac troponin T [cTnT]) > ULN if cTnI is not available). In such a case, the assessment may be repeated once.
  • Participant has a mean pulse < 45 or > 100 bpm; mean systolic blood pressure > 160 mmHg; mean diastolic blood pressure > 100 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
  • Participant has a mean QT interval using Fridericia's correction (QTcF) of > 460 msec for male participants and > 480 msec for female participants on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
  • Participant who has had a change in dose regimen of medically required medication(s) in the 2 weeks prior to screening (permitted concomitant medications) and/or participant for whom dose changes are likely to occur during the study (minor dose changes are allowed in agreement with the sponsor) and/or participant has used nonpermitted concomitant medication(s) in the 3 weeks prior to admission to the clinical unit (nonpermitted concomitant medications include any known hepatic enzyme-altering agents, compounds, vitamins or natural herbal remedies, e.g., St. John's Wort known to restrict metabolism).
  • Participant has a history of consuming > 14 units for male participants and > 7 units for female participants of alcoholic beverages per week within 3 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within 1 year prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the participant tests positive for alcohol at screening or on day -1.
  • Participant has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or on day -1, unless the positive test is due to prescription drug use that is approved by the principal investigator and sponsor.
  • Participant has a positive serology test for hepatitis A virus antibodies (IgM), hepatitis B surface antigen (HBsAg) or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening.
  • Participant has fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period (e.g., advanced ascites, infection of ascites, fever, active gastrointestinal bleeding).
  • Participant has a presence of a hepatocellular carcinoma, or an acute liver disease caused by an infection or drug toxicity.
  • Participant has severe portal hypertension or surgical portosystemic shunts, including transjugular intrahepatic portosystemic shunt.
  • Participant has biliary liver cirrhosis, biliary obstruction or other cause of hepatic impairment not related to parenchymal disorder and/or disease of the liver.
  • Participant has signs of significant hepatic encephalopathy (hepatic encephalopathy grade ≥ 2).
  • Participant has severe ascites and/or pleural effusion.
  • Participant has esophageal or gastric varices which have a high risk of clinically significant hemorrhage.
  • Participant has thrombocyte level below 40 × 10^9/L and/or hemoglobin < 90 g/L.
  • Participant has had previous liver transplantation.
  • Additional Criteria for Healthy Participants with Normal Hepatic Function:
  • Participant has any of the liver function tests (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and total bilirubin) ≥ 1 × ULN or international normalized ratio > 1.1 on day -1. In such a case, the assessment may be repeated once.
  • Participant has cTnI > ULN (or cTnT > ULN if cTnI is not available) at screening.
  • Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
  • Participant has any clinically significant abnormality following the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on day -1.
  • Participant has a mean pulse < 45 or > 90 bpm; mean SBP > 150 mmHg; mean DBP > 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
  • Participant has a mean QTcF of > 430 msec for male participants > 450 msec for female participants on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
  • Participant has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to IP administration, except for occasional use of acetaminophen (up to 2 g/day), topical dermatological products (including corticosteroid products), hormonal contraceptives and hormone replacement therapy.
  • Participant has a history of consuming > 14 units for male participants and > 7 units for female participants of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within 2 years prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the participant tests positive for alcohol at screening or on day -1.
  • Participant has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or on day -1.
  • Participant has a positive serology test for HAV antibodies (IgM), hepatitis B surface antigen, HCV antibodies or antibodies to HIV type 1 and/or type 2 at screening.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147

  • Orlando Clinical Research Center, Inc

    Orlando, Florida, 32809

  • Texas Liver Institute

    San Antonio, Texas, 78215

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
Bocidelpar
Keywords
Mild and moderate hepatic impairment, Liver function, ASP0367, Pharmacokinetics, MA-0211, Healthy Volunteers
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BocidelparDrug

    Also called MA-0211, ASP0367

    Oral

Study groups in NCT04942964
Study groupRoleWhat they receive
ASP0367: Mild Hepatic ImpairmentExperimentalParticipants with mild hepatic impairment will receive a single dose of ASP0367 under fasting conditions on day 1.
Receives: Drug: Bocidelpar
ASP0367: Moderate Hepatic ImpairmentExperimentalParticipants with moderate hepatic impairment will receive a single dose of ASP0367 under fasting conditions on day 1.
Receives: Drug: Bocidelpar
ASP0367: Normal Hepatic FunctionExperimentalParticipants with normal hepatic function will receive a single dose of ASP0367 under fasting conditions on day 1.
Receives: Drug: Bocidelpar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 5 days

  2. 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.

    Measured: Up to 5 days

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

    Cmax will be recorded from the PK plasma samples collected.

    Measured: Up to 5 days

Secondary outcomes (4)

  1. Number of Participants with Adverse Events (AEs)

    Adverse Events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant, temporally associated with the use of investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP. This includes events related to the comparator and events related to the (study) procedures.

    Measured: Up to Day 16

  2. Number of Participants with Laboratory Value Abnormalities and/or AEs

    Number of participants with potentially clinically significant laboratory values

    Measured: Up to Day 16

  3. Number of Participants with Vital Sign Abnormalities and/or AEs

    Number of participants with potentially clinically significant vital signs values.

    Measured: Up to Day 16

  4. Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or AEs

    Number of participants with potentially clinically significant 12-Lead ECG values.

    Measured: Up to Day 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study start13 Sep 2021
  3. Primary completion11 Jan 2022
  4. Study completion20 Jan 2022

Resources

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04942964
Sponsor's protocol ID
0367-CL-1102
Status last verified
Oct 2024
First submitted
21 Jun 2021
Last updated
21 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Iwai M, Heo N, Hashimoto K, Guro S, Moy S, Spence A, Wojtkowski T, Benner L, Helmick M, Zhu T, Ferslew BC. Pharmacokinetics of Bocidelpar, ASP0367, in Renal and Hepatic Impairment: Results From Two Phase 1 Studies. Clin Transl Sci. 2025 Aug;18(8):e70310. doi: 10.1111/cts.70310.

    PubMed 40748778

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bocidelpar in people with Hepatic Impairment and Healthy Volunteers, run by Astellas Pharma Global Development, Inc. at 3 sites 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 12 inclusion and 45 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

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). 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?

On the ClinicalTrials.gov record for NCT04942964, which also lists 1 linked publication.

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 21 Oct 2024.

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