A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment

Kidney Diseases Clinical Trial

Official title:

A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05624710
• Other study ID #: INCB 54707-105
• Status: Completed
• Phase: Phase 1
• Start date: December 8, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Participants with hepatic impairment will be classified at screening based on Child-Pugh score. Classification will be repeated at check-in and should not be significantly different.

If the hepatic function classification for the participant is not similar at the 2 timepoints, enrollment of the participant into a hepatic category group will be at the discretion of the investigator, in consultation with the sponsor's medical monitor. The enrollment group will be based on the results at screening.

• Participants eligible for Group 4 (normal hepatic function) should be in good health as determined by no clinically significant findings in the medical history, physical examination, vital signs, 12-lead ECGs, or laboratory examinations at screening or check-in.

• Participants eligible for Groups 1 through 3 may have medical findings consistent with their degree of hepatic dysfunction, as determined by medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory examinations at screening and check-in. Participants with abnormal findings considered not clinically significant by the investigator are eligible.

• BMI within the range of 18.0 to 44.0 kg/m2 (inclusive) at screening.

• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• the opinion of the principal investigator, history of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening or evidence of rapidly deteriorating hepatic function.

• Serum corrected calcium and phosphorus levels over the upper limits of the institutional normal ranges.

• History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:

1. Recent myocardial infarction (within 6 months of check-in).

2. New York Heart Association Class III or IV congestive heart failure.

3. Unstable angina (within 6 months of check-in).

4. Clinically significant (symptomatic) cardiac arrhythmias (eg, sustained ventricular tachycardia, second or third degree atrioventricular block without a pacemaker).

5. Uncontrolled hypertension.

• A current, functioning organ transplant or a scheduled organ transplant in the next 6 weeks from check-in.

• History of malignancy within 5 years of screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.

• History of clinically significant GI disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.

• Severe ascites (ascites requiring paracentesis more than every 4 weeks) or an encephalopathy = Grade 2 (precludes them from understanding and signing an informed consent).

• Any major surgery within 4 weeks of screening.

• Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only).

• Blood transfusion within 4 weeks of check-in.

• Current or recent history (within 30 days before screening) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection, or currently receiving systemic antibiotics or current clinically significant viral infection at screening or check-in.

• Positive serology for HBV (eg, HBsAg) or HIV. Participants whose results are compatible with immunity due to infection or prior immunization for HBV may be included at the discretion of the investigator.

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency

Intervention

Drug:
• INCB054707
INCB054707 75 mg will be administered orally on Day 1.

Locations

Country	Name	City	State
Germany	Apex Gmbh	Munich
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office	San Antonio	Texas
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics Parameter: Cmax of INCBC054707	Defined as maximum observed plasma concentration of INCB054707	Days 1 - 5
Primary	Pharmacokinetics Parameter: AUC(0-t) of INCB054707	Defined as the area under the concentration- time curve up to the last measurable concentration of INCB54707.	Days 1 - 5
Primary	Pharmacokinetics Parameter: AUC(0-8) of INCB054707	Defined as area under the concentration-time curve From 0 to Infinity of INCB054707	Days 1 - 5
Secondary	Number of Treatment Emergent Adverse Events (TEAE'S)	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.	up to 15 days
Secondary	Pharmacokinetics Parameter: tmax of INCB054707	Defined as time to reach maximum plasma concentration of INCB054707	Days 1 - 5
Secondary	Pharmacokinetics Parameter: t1/2 0f INCB054707	Defined as apparent terminal phase disposition half-life of INCB54707	Days 1 - 5
Secondary	Pharmacokinetics Parameter: CL/F of INCB054707	Defined as oral dose clearance of INCB054707	Days 1 - 5
Secondary	Pharmacokinetics Parameter:: Vz/F of INCB054707	Defined as apparent oral dose volume of distribution of INCB054707	Days 1 - 5