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

Sponsor

Incyte Biosciences Japan GK (Industry)

Overall Status

Completed

CT.gov ID

NCT05068466

Collaborator

(none)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: INCB054707 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 21, 2021

Actual Primary Completion Date :

Jan 25, 2022

Actual Study Completion Date :

Jan 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INCB054707 (Dose A) Participants will be administered single-dose INCB054707 on Day 1 followed by once daily dose of INCB054707 on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours	Drug: INCB054707 Administered Orally
Experimental: INCB054707 (Dose B) Participants will be administered a single-dose INCB054707 on Day 1 followed by once daily dose of INCB54707 on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours.	Drug: INCB054707 Administered Orally
Placebo Comparator: Placebo (Dose A) Participants will be administered single-dose placebo on Day 1 followed by once daily dose of placebo on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours	Drug: Placebo Administered Orally
Placebo Comparator: Placebo (Dose B) Participants will be administered single-dose placebo on Day 1 followed by once daily dose of placebo on Days 5 to 12 (8 doses) administered orally after a fast of ≥ 8 hours	Drug: Placebo Administered Orally

Outcome Measures

Primary Outcome Measures

Number of participants with Treatment Emergent Adverse Events (TEAE'S) [3 months]
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Pharmacokinetics Parameter : Cmax of INCB054707 [17 Days]
Maximum Observed Plasma Concentration of INCB054707
Pharmacokinetics Parameter : Cmin of INCB054707 [17 Days]
Minimum Observed Plasma Concentration of INCB054707
Pharmacokinetics Parameter : tmax of INCB054707 [17 Days]
Time to reach maximum plasma concentration of INCB054707
Pharmacokinetics Parameter : AUC(0-t) of INCB054707 [17 Days]
Area Under the concentration- time curve up to the last measurable concentration of INCB054707
Pharmacokinetics Parameter : AUC(0-∞) of INCB054707 [17 Days]
Area Under the Concentration-time Curve From 0 to Infinity of INCB054707
Pharmacokinetics Parameter : AUC(0-tau) of INCB054707 [17 Days]
Area under the single-dose or steady-state plasma concentration-time curve from hour 0 to the end of the dosing period of INCB054707

Secondary Outcome Measures

Pharmacokinetics Parameter : t1/2 of INCB054707 [17 Days]
Pharmacokinetics Parameter : t1/2 of Apparent terminal phase disposition half-life of
Pharmacokinetics Parameter : CL/F of INCB054707 [17 Days]
Oral dose clearance of INCB054707
Pharmacokinetics Parameter : Vz/F of INCB054707 [17 Days]
Apparent oral dose volume of distribution of INCB54707
Pharmacokinetics Parameter : Cavg of INCB054707 [17 Days]
Average plasma concentration at steady state of INCB054707
Pharmacokinetics Parameter : λz of INCB054707 [17 Days]
Apparent terminal-phase disposition rate constant of INCB054707

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Souseikai Fukuoka Mirai Hospital	Fukuoka		Japan	813-0017

Sponsors and Collaborators

Incyte Biosciences Japan GK

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Incyte Biosciences Japan GK

ClinicalTrials.gov Identifier:

NCT05068466

Other Study ID Numbers:

INCB 54707-108

First Posted:

Oct 5, 2021

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Incyte Biosciences Japan GK

INCB054707

Study Results

No Results Posted as of Apr 29, 2022