Renal Impairment study: INCB123667
Official title A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease
ClinicalTrials.gov ID: NCT07559396
What this study is testing
What is INCB123667?
an investigational oral medicine being studied for safety and pharmacokinetics in adults with severe renal impairment or end‑stage renal disease
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 aims to find out if the drug is safe and how the body processes it in people with serious kidney issues.
- Who it's for
- The study is looking for adults who have severe kidney impairment or end-stage renal disease.
- What's involved
- Participants will take the drug by mouth and undergo tests to check for safety and measure drug levels in the body.
- Time commitment
- The source text does not specify the duration or number of visits required.
- 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 85
You may be able to join if
- Aged 18 to 85 years, inclusive, at the time of signing the ICF.
- Severe renal impairment or ESRD based on CKD-EPI.
- Body mass index of 18.0 to 43.0 kg/m2 (inclusive).
- Willingness to avoid pregnancy or fathering children.
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...
- Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening.
- 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 3 months prior to check-in.
- Participants who required new medication or an increase in dose for renal disease within 3 months prior to check-in.
See the full eligibility criteria
- Aged 18 to 85 years, inclusive, at the time of signing the ICF.
- Severe renal impairment or ESRD based on CKD-EPI.
- 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.
- Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening.
- 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 3 months prior to check-in.
- Participants who required new medication or an increase in dose for renal disease within 3 months prior to check-in.
- Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%).
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami Lakes, Florida, United States
- Orlando, Florida, 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, but 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 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami Lakes, Florida, United States; Orlando, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.