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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INCB123667.
- Who it may be relevant to
- Registry conditions: Renal Impairment. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease
Overview
This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.
Interventions
- Drug INCB123667
Group 1: Single dose administered orally. Group 2: Two single doses administered orally.
Primary outcome measures
- PK for plasma INCB123667: Cmax [Time frame: Up to approximately 3 months]
- PK for plasma INCB123667: AUCt [Time frame: Up to approximately 3 months]
- PK for plasma INCB123667: AUC∞ [Time frame: Up to approximately 3 months]
Secondary outcome measures (1)
- Number of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to approximately 3.5 months]
Eligibility criteria
Inclusion 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.
Exclusion criteria
- 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. Participants with out-of-range values will be assessed by the investigator or designee for eligibility.
- 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%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical monitor.
- 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 Criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Floridian Clinical Research — Miami Lakes
- Orlando Clinical Research Center — Orlando
Identifiers
NCT: NCT07559396 · INCB123667-105