A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of INCB054707

Healthy Participants Clinical Trial

Official title:

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB054707 When Administered Orally to Healthy Japanese Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05068466
• Other study ID #: INCB 54707-108
• Status: Completed
• Phase: Phase 1
• Start date: October 21, 2021
• Est. completion date: January 25, 2022

Study information

• Verified date: September 2022
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, randomized, double-blind, placebo-controlled, sponsor-unblinded, Phase 1 study designed to evaluate the safety, tolerability, and PK of escalating oral doses of INCB054707 in healthy male Japanese participants. Participants in each cohort will be divided into placebo or INCB054707 by a 3:1 INCB054707:placebo random assignment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male healthy Japanese adult participants aged 20 to 55 years with a minimum weight of 48 kg.

• Body mass index between 18.0 and 30.5 kg/m2.

• No clinically significant findings in screening evaluations.

• Ability to swallow and retain oral medication.

• Willingness to avoid fathering children

Exclusion Criteria:

• History of clinically significant cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease.

• History of rheumatologic/autoimmune disorders, except for minor eczema and rosacea.

• Resting pulse < 40 bpm or > 100 bpm, confirmed by repeat testing at screening.

• History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant.

• Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).

• Hemoglobin, WBC, platelet, or ANC that is out of the laboratory's range unless considered clinically insignificant by the investigator at screening or check-in.

• History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin.

• Current or recent (within 6 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy, excluding appendectomy) that could affect the absorption of study drug.

• Any major surgery within 6 months of screening.

• Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for plasma donation).

• Blood transfusion within 4 weeks of check-in.

• Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment

• Positive test for HIV and known active HBV or HCV infection or risk of reactivation of HBV or HCV.

• History of alcoholism within 3 months of screening.

• Positive breath or urine test for ethanol or positive urine screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.

• Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug study.

• Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with an inducer or inhibitor of CYP3A4, P-gp, or BCRP

• Current use of prohibited medication

• Consumption of Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 72 hours before the first dose of study drug.

• History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.

• Known hypersensitivity or severe reaction to INCB054707 or any excipients of INCB054707

• Inability to undergo venipuncture or tolerate venous access.

• Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.

• History of tobacco- or nicotine-containing product use within 1 month of screening.

• Use of prescription drugs within 14 days of study drug administration or nonprescription medications/products within 7 days of study drug administration.

• Any condition that would, in the investigator's judgment, interfere with full participation in the study.

• Positive syphilis test.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• INCB054707
Administered Orally
• Placebo
Administered Orally

Locations

Country	Name	City	State
Japan	Souseikai Fukuoka Mirai Hospital	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Biosciences Japan GK

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with 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.	3 months
Primary	Pharmacokinetics Parameter : Cmax of INCB054707	Maximum Observed Plasma Concentration of INCB054707	17 Days
Primary	Pharmacokinetics Parameter : Cmin of INCB054707	Minimum Observed Plasma Concentration of INCB054707	17 Days
Primary	Pharmacokinetics Parameter : tmax of INCB054707	Time to reach maximum plasma concentration of INCB054707	17 Days
Primary	Pharmacokinetics Parameter : AUC(0-t) of INCB054707	Area Under the concentration- time curve up to the last measurable concentration of INCB054707	17 Days
Primary	Pharmacokinetics Parameter : AUC(0-8) of INCB054707	Area Under the Concentration-time Curve From 0 to Infinity of INCB054707	17 Days
Primary	Pharmacokinetics Parameter : AUC(0-tau) of INCB054707	Area under the single-dose or steady-state plasma concentration-time curve from hour 0 to the end of the dosing period of INCB054707	17 Days
Secondary	Pharmacokinetics Parameter : t1/2 of INCB054707	Pharmacokinetics Parameter : t1/2 of Apparent terminal phase disposition half-life of	17 Days
Secondary	Pharmacokinetics Parameter : CL/F of INCB054707	Oral dose clearance of INCB054707	17 Days
Secondary	Pharmacokinetics Parameter : Vz/F of INCB054707	Apparent oral dose volume of distribution of INCB54707	17 Days
Secondary	Pharmacokinetics Parameter : Cavg of INCB054707	Average plasma concentration at steady state of INCB054707	17 Days
Secondary	Pharmacokinetics Parameter : ?z of INCB054707	Apparent terminal-phase disposition rate constant of INCB054707	17 Days