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

NCT05068466 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB 54707-108
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

INCB054707

Outcome Measures

Primary Outcomes (7)

• 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

• Pharmacokinetics Parameter : Cmax of INCB054707

  Maximum Observed Plasma Concentration of INCB054707

  17 Days

• Pharmacokinetics Parameter : Cmin of INCB054707

  Minimum Observed Plasma Concentration of INCB054707

  17 Days

• Pharmacokinetics Parameter : tmax of INCB054707

  Time to reach maximum plasma concentration of INCB054707

  17 Days

• Pharmacokinetics Parameter : AUC(0-t) of INCB054707

  Area Under the concentration- time curve up to the last measurable concentration of INCB054707

  17 Days

• Pharmacokinetics Parameter : AUC(0-∞) of INCB054707

  Area Under the Concentration-time Curve From 0 to Infinity of INCB054707

  17 Days

• 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 Outcomes (5)

• Pharmacokinetics Parameter : t1/2 of INCB054707

  17 Days

• Pharmacokinetics Parameter : CL/F of INCB054707

  17 Days

• Pharmacokinetics Parameter : Vz/F of INCB054707

  17 Days

• Pharmacokinetics Parameter : Cavg of INCB054707

  17 Days

• Pharmacokinetics Parameter : λz of INCB054707

  17 Days

Study Arms (4)

INCB054707 (Dose A)

EXPERIMENTAL

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

INCB054707 (Dose B)

EXPERIMENTAL

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

Placebo (Dose A)

PLACEBO COMPARATOR

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

Placebo (Dose B)

PLACEBO COMPARATOR

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

Interventions

INCB054707 DRUG

Administered Orally

Also known as: Povorcitinib

INCB054707 (Dose A); INCB054707 (Dose B)

Placebo DRUG

Administered Orally

Placebo (Dose A); Placebo (Dose B)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Biosciences Japan GK: lead

Study Sites (1)

Souseikai Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 5, 2021
• Study Start: October 21, 2021
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

JP (1)