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A Phase 1, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics Of Mavodelpar In Subjects With Impaired Hepatic Function
EU CTIS ID: 2023-504007-91-00
What this study is testing
Primary objective to evaluate the effect of impaired hepatic function on the single dose PK of mavodelpar (25 mg) oral capsule.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female subjects, between 18 and 70 years of age, inclusive.
- Female subjects of childbearing potential must have negative pregnancy test results at Screening and Check-in.
- Must agree to adhere to the contraception requirements defined in Section 6.4.4.
- BMI of 18.0-40.0 kg/m2 at Screening. BMI = body weight (kg) / [height (m)]2.
- Subjects with HI: Has impaired hepatic function as defined by the Child-Pugh classification (Appendix A) for severity of liver disease and has a Child-Pugh score in line with one of the following HI groups at Screening: Group 2; mild (Class A); Child-Pugh score 5-6, inclusive. Group 3; moderate (Class B); Child-Pugh score 7-9, inclusive. Group 4; severe (Class C); Child-Pugh score 10-15, inclusive.
- Healthy Subjects: Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the Investigator or designee.
You likely can't join if
- Previously received mavodelpar.
- Female subjects of childbearing potential who are pregnant or lactating.
- An employee or contractor of the facility conducting the study, or a family member of the Investigator, site staff, or Sponsor.
- Administration of an investigational agent in a clinical study in the past 30 days (or 5 multiples of half-life, whichever is longer) before dosing.
- Medical illness or other concern which would cause the Investigator to conclude that the subject will not be able to perform the study procedures or assessments or would confound interpretation of data obtained during assessment.
- Medical history of cardiac disease and/or clinically significant ECG abnormalities.
See the full eligibility criteria
- Male and female subjects, between 18 and 70 years of age, inclusive.
- Female subjects of childbearing potential must have negative pregnancy test results at Screening and Check-in.
- Must agree to adhere to the contraception requirements defined in Section 6.4.4.
- BMI of 18.0-40.0 kg/m2 at Screening. BMI = body weight (kg) / [height (m)]2.
- Subjects with HI: Has impaired hepatic function as defined by the Child-Pugh classification (Appendix A) for severity of liver disease and has a Child-Pugh score in line with one of the following HI groups at Screening: Group 2; mild (Class A); Child-Pugh score 5-6, inclusive. Group 3; moderate (Class B); Child-Pugh score 7-9, inclusive. Group 4; severe (Class C); Child-Pugh score 10-15, inclusive.
- Healthy Subjects: Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the Investigator or designee.
- Previously received mavodelpar.
- Female subjects of childbearing potential who are pregnant or lactating.
- An employee or contractor of the facility conducting the study, or a family member of the Investigator, site staff, or Sponsor.
- Administration of an investigational agent in a clinical study in the past 30 days (or 5 multiples of half-life, whichever is longer) before dosing.
- Medical illness or other concern which would cause the Investigator to conclude that the subject will not be able to perform the study procedures or assessments or would confound interpretation of data obtained during assessment.
- Medical history of cardiac disease and/or clinically significant ECG abnormalities.
- Pulse rate is lower than 40 bpm or higher than 99 bpm at screening.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.