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Tests treatment safety and results for Hepatic Insufficiency
Official title A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment
ClinicalTrials.gov ID: NCT07559474
What this study is testing
What is INCB123667?
INCB123667 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hepatic insufficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with moderate or severe hepatic impairment.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Ability to comprehend and willingness to sign a written ICF for the study.
- Aged 18 to 80 years, inclusive, at the time of signing the ICF.
- Moderate or severe hepatic impairment based on CP score.
- Medical findings consistent with the degree of hepatic dysfunction, determined by medical history, physical examination, vital sign measurements...
- Body mass index of 18.0 to 43.0 kg/m2 (inclusive).
You likely can't join if
- Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3...
- Tobacco or nicotine-containing product use of \> 10 cigarettes per day within 1 month before screening.
- Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed...
- Participants who have a history of paracentesis within 2 months prior to check-in.
- Participants who required new medication or an increase in dose for hepatic encephalopathy within 3 months prior to check-in.
- Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes...
See the full eligibility criteria
- Ability to comprehend and willingness to sign a written ICF for the study.
- Aged 18 to 80 years, inclusive, at the time of signing the ICF.
- Moderate or severe hepatic impairment based on CP score.
- Medical findings consistent with the degree of hepatic dysfunction, determined by medical history, physical examination, vital sign measurements, 12-lead ECGs, and clinical laboratory determinations at screening or...
- Body mass index of 18.0 to 43.0 kg/m2 (inclusive).
- Willingness to avoid pregnancy or fathering children.
- Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months.
- Tobacco or nicotine-containing product use of \> 10 cigarettes per day within 1 month before screening.
- Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed clinically significant by the investigator.
- Participants who have a history of paracentesis within 2 months prior to check-in.
- Participants who required new medication or an increase in dose for hepatic encephalopathy within 3 months prior to check-in.
- Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical...
- Participants who had esophageal banding within 3 months prior to check-in or required any other treatment for gastrointestinal bleeding within 6 months prior to check-in. Other protocol-defined Inclusion/Exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Orlando, Florida, United States
- San Antonio, Texas, United States
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 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Orlando, Florida, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.