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

JRCT ID: jRCT2071210079

Registered date:18/10/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Inflammatory disease
• Date of first enrollment: 21/10/2021
• Target sample size: 30
• Study type: Interventional

Intervention(s)

- Dose A
INCB054707 or placebo;
Participants will be administered single-dose INCB054707 or placebo on Day 1 followed by once daily dose of INCB054707 or placebo on Days 5 to 12 (8 doses) administered orally after a fast of >= 8 hours.

- Dose B
INCB054707 or placebo;
Participants will be administered single-dose INCB054707 or placebo on Day 1 followed by once daily dose of INCB054707 or placebo on Days 5 to 12 (8 doses) administered orally after a fast of >= 8 hours.

Outcome(s)

Primary Outcome

1. Number of participants with Treatment Emergent Adverse Events (TEAES)
2. Pharmacokinetics Parameter : Cmax, Cmin, tmax, AUC(0-t), AUC(0-infinity) and AUC(0-tau) of INCB054707

• Secondary Outcome: Pharmacokinetics Parameter : t1/2, CL/F, Vz/F, Cavg and Lz of INCB054707

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 55age old
• Gender: Male

Include 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.

Exclude 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 Information

• Primary Sponsor: On Shintaro
• Secondary ID(s): NCT05068466