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CompletedNCT05751759Updated Dec 5, 2024

Pharmacokinetics of Mitiperstat in Participants With Hepatic Impairment

A Phase 1 interventional study of Mitiperstat in Hepatic Impairment, sponsored by AstraZeneca. Completed at 5 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2024, 1 year 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
31
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of mitiperstat.

Read the detailed description

This is a Phase I, single dose, non-randomised, open-label, parallel group study to examine the PK, safety, and tolerability of mitiperstat in participants with hepatic impairment and participants with normal hepatic function.

Participants will be assigned to one of the following cohorts as per Child-Pugh classification:

  • Cohort 1: Eight participants with Mild hepatic impairment (Child-Pugh A)
  • Cohort 2: Eight participants with Moderate hepatic impairment (Child-Pugh B)
  • Cohort 3: Six to eight participants with Severe hepatic impairment (Child-Pugh C)
  • Cohort 4: Eight to twelve participants with Normal hepatic function

A final safety follow-up visit on Day 21 will be there after all procedures are completed on Day 15.

02

Conditions studied

  • Hepatic Impairment

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Keywords

  • Hepatic impairment
  • Liver disease
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 31 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant must be ≥ 18 to ≤ 85 years (inclusive), at the time of signing the informed consent.
  • Weight ≥ 50kg and BMI ≥ 18 kg/m2 up to \< 42 kg/m2.
  • Male and/or females.

  • Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    1. Criterion not applicable to this CSP version.

    2. Female participants:

      • Female participants must not be lactating.
      • Female participants of childbearing potential who are sexually active with a non-sterilised male partner must agree to use an acceptable method of birth control, from enrolment throughout the study and until at least 4 weeks after the last dose of study intervention.
  • Capable of giving signed informed consent.

Participants with hepatic impairment only:

  • Supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available.
  • Diagnosis of chronic and stable hepatic impairment.

Exclusion criteria

Exclusion Criteria:

  • Any positive result on screening for serum or plasma hepatitis B surface antigen, hepatitis C antibody, and HIV.
  • History of substance dependence or a positive screen for drugs of abuse, likely to impact participant safety or compliance with study procedures.
  • History of alcohol abuse or excessive intake of alcohol in the last 12 months.
  • Abnormal vital signs, after 10 minutes supine rest at screening or Day -1.
  • Any clinically important abnormalities in rhythm, conduction or morphology of the resting 12-lead ECG at screening or Day -1:
  • Vulnerable participants.
  • For female participants only: currently pregnant or breast-feeding.

Participants with hepatic impairment only

  • Participants with previous transjugular intrahepatic portosystemic shunt (TIPS).
  • Severe ascites defined as ascites requiring paracentesis and albumin at 4-week intervals or less.
  • 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.
  • Any evidence of additional severe or uncontrolled systemic disease or laboratory finding that makes it unsafe for the participant to participate in the study.
  • Change in dose regimen of medically-required medication within the last 2 weeks before pre-study examination.
  • Biliary obstruction or other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver.
  • Clinically relevant hepatic encephalopathy.
  • Oesophageal variceal bleeding in prior 3 months.
  • Platelet count \< 50 × 109/L and/or neutrophil count \< 1.2 × 109/L and/or haemoglobin \< 85 g/L.
  • Post liver transplantation.
  • History of acute or chronic pancreatitis, or pancreatic amylase or lipase greater than twice the ULN at screening.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Cohort 1

    8 participants with mild hepatic impairment (Child-Pugh A) will be given Dose A of mitiperstat.

    Drug: Mitiperstat

  • Experimental
    Cohort 2

    8 participants with moderate hepatic impairment (Child-Pugh B) will be given Dose A of mitiperstat.

    Drug: Mitiperstat

  • Experimental
    Cohort 3

    6-8 participants with severe hepatic impairment (Child-Pugh C) will be given Dose A of mitiperstat.

    Drug: Mitiperstat

  • Experimental
    Cohort 4

    8-12 participants with normal hepatic function will be given Dose A of mitiperstat.

    Drug: Mitiperstat

Interventions

  • DrugMitiperstat

    Participants receive mitiperstat orally.

    Also known as: AZD4831

06

What researchers measure

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    The Cmax of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.

    Time frame: Day 1 to Day 15

  2. Area under the concentration-time curve from time zero to infinity (AUCinf)

    The AUCinf of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.

    Time frame: Day 1 to Day 15

  3. Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)

    The AUClast of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.

    Time frame: Day 1 to Day 15

  4. Apparent terminal elimination half-life (t½λz)

    The t½λz of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.

    Time frame: Day 1 to Day 15

  5. Time to Cmax (tmax)

    The tmax of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.

    Time frame: Day 1 to Day 15

  6. Apparent Clearance (CL/F)

    The CL/F of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.

    Time frame: Day 1 to Day 15

  7. Volume of distribution (apparent) following extravascular administration [based on terminal phase] (Vz/F)

    The Vz/F of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.

    Time frame: Day 1 to Day 15

  8. Cumulative amount of unchanged drug excreted into urine (Ae[0-24])

    The Ae(0-24) of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.

    Time frame: Day 1 to Day 15

  9. Renal clearance of drug from plasma (CLR)

    The CLR of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.

    Time frame: Day 1 to Day 15

  10. Non-renal clearance of drug from plasma (CLNR)

    The CLNR of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.

    Time frame: Day 1 to Day 15

  11. Percentage of dose excreted unchanged in urine from time 0 to time 24 (fe[0-24)

    The fe(0-24) of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.

    Time frame: Day 1 to Day 15

Secondary outcomes

  1. Adverse Events (AEs), and Serious Adverse Events (SAEs)

    The safety, and tolerability of a single dose of mitiperstat in participants with hepatic impairment and controls with normal hepatic function will be assessed.

    Time frame: From time of dose to the final follow-up visit (Day 21 [± 4 days])

07

Study locations

5 sites
  • Research Site
    Rialto, California 92377, United States
  • Research Site
    Hialeah, Florida 33016, United States
  • Research Site
    Orlando, Florida 32808, United States
  • Research Site
    Canton, Ohio 44718, United States
  • Research Site
    San Antonio, Texas 78215, United States
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05751759
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Mar 2, 2023
Start date
Mar 20, 2023
Primary completion
Nov 21, 2024
Completion
Nov 21, 2024
Last update
Dec 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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