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

Incyte Biosciences Japan GK1 site in 1 country30 target enrollmentOctober 21, 2021

ConditionsHealthy Participants

InterventionsINCB054707 Placebo

DrugsINCB054707 Placebo

Overview

Phase: Phase 1
Intervention: INCB054707
Conditions: Healthy Participants
Sponsor: Incyte Biosciences Japan GK
Enrollment: 30
Locations: 1
Primary Endpoint: Pharmacokinetics Parameter : Cmax of INCB054707
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 21, 2021

End Date

January 25, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Incyte Biosciences Japan GK

Responsible Party

Sponsor

Eligibility Criteria

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/m
•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).

Arms & Interventions

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

Intervention: INCB054707

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.

Intervention: INCB054707

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

Intervention: Placebo

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

Intervention: Placebo