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NCT Number: NCT07559396

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

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Floridian Clinical Research, Miami Lakes, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INCB123667

Drug

Group 1: Single dose administered orally. Group 2: Two single doses administered orally.

Primary outcomes

  1. PK for plasma INCB123667: Cmax

    Time frame: Up to approximately 3 months

    Defined as the maximum plasma concentration.

  2. PK for plasma INCB123667: AUCt

    Time frame: Up to approximately 3 months

    Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.

  3. PK for plasma INCB123667: AUC∞

    Time frame: Up to approximately 3 months

    Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.

Secondary outcomes

  1. Number of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 3.5 months

    Adverse events reported for the first time or worsening of a pre-existing event, occurring after study drug/treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

[email protected]

+800 00027423

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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