A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participant
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Dose-Escalation, Drug-Interaction, and Food-Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participants
1 other identifier
interventional
137
1 country
1
Brief Summary
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2024
CompletedFirst Posted
Study publicly available on registry
January 19, 2024
CompletedStudy Start
First participant enrolled
March 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2025
CompletedOctober 14, 2025
October 1, 2025
1.4 years
January 10, 2024
October 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Up to Day 28
INCB160058 pharmacokinetic (PK) when administered as solid tablets in Plasma
INCB160058 concentration in plasma.
Up to Day 5
INCB160058 pharmacokinetic (PK) when administered as a soft gel capsule in Plasma
INCB160058 concentration in plasma.
Up to Day 5
INCB160058 pharmacokinetic (PK) when administered as ASD tablets in Plasma
INCB160058 concentration in plasma.
Up to Day 5
INCB160058 pharmacokinetic (PK) in Plasma to determine the effect of food administered as solid tablets
INCB160058 concentration in plasma.
Up to Day 12
INCB160058 pharmacokinetic (PK) in Plasma to determine the effect of food administered as ASD tablets
INCB160058 concentration in plasma.
Up to Day 12
INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of esomeprazole administered as solid tablets
INCB160058 concentration in plasma.
Up to Day 14
INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of esomeprazole administered as ASD tablets
INCB160058 concentration in plasma.
Up to Day 14
INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of famotidine administered as solid tablets
INCB160058 concentration in plasma.
Up to Day 14
INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of famotidine administered as ASD tablets
INCB160058 concentration in plasma.
Up to Day 14
Secondary Outcomes (2)
Additional INCB160058 pharmacokinetic (PK) in Plasma
Up to Day 14
INCB160058 pharmacokinetic (PK) in Urine
Up to Day 5
Study Arms (17)
Cohort 1: Dose
EXPERIMENTALINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 2: Dose
EXPERIMENTALINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 3: Dose
EXPERIMENTALINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 4: Dose
EXPERIMENTALINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 5: Dose
EXPERIMENTALINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 6: Dose Treatment A
EXPERIMENTALINCB160058 will be administered at protocol defined dose after an overnight fast.
Cohort 6: Dose Treatment B
EXPERIMENTALINCB160058 will be administered at protocol defined dose after a high-fat, high-calorie meal.
Cohort 7: Dose
EXPERIMENTALINCB160058 and esomeprazole will be administered at protocol defined schedule and dose.
Cohort 8: Dose
EXPERIMENTALINCB160058 will be administered at protocol defined dose after an overnight fast.
Cohort 9: Dose
EXPERIMENTALINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 10: Dose Treatment A
EXPERIMENTALINCB160058 will be administered at protocol defined dose after an overnight fast.
Cohort 10: Dose Treatment B
EXPERIMENTALINCB160058 will be administered at protocol defined dose after a high-fat, high-calorie meal.
Cohort 11: Dose
EXPERIMENTALINCB160058 and esomeprazole will be administered at protocol defined schedule and dose.
Cohort 12: Dose
EXPERIMENTALINCB160058 and famotidine will be administered at protocol defined schedule and dose.
Cohort 13: Dose
EXPERIMENTALINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Cohort 14: Dose
EXPERIMENTALINCB160058 and famotidine will be administered at protocol defined schedule and dose.
Cohort 15: Dose
EXPERIMENTALINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Interventions
Oral; Immediate release solid tablet
Oral; Tablet
Eligibility Criteria
You may qualify if:
- Ability to comprehend and willingness to sign a written ICF for the study.
- Age 18 to 55 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 32.0 kg/m2 (inclusive).
- Willingness to adhere to study-related prohibitions, restrictions, and procedures.
- Ability to swallow and retain oral medication.
- Willingness to avoid pregnancy or fathering children based on the criteria below.
- Male participants with reproductive potential must agree to use 1 of the highly effective methods of contraception to avoid fathering children from screening through the last follow-up visit and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
- Female participants who are WOCBP must have a negative pregnancy test at screening and check-in, must agree to use 1 of the highly effective methods of contraception to avoid pregnancy from screening through the last follow-up visit, and must refrain from donating oocytes during this period.
- Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed. Positive pregnancy tests may be confirmed at the investigator's discretion.
- Female participants not considered to be of childbearing potential are eligible and must have a negative pregnancy test at screening and check-in.
You may not qualify if:
- History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- History of rheumatologic/autoimmune disorders and immune deficiency/immunologic defects.
- Prior history of major bleeding or thrombosis, including myocardial infarction/stroke and pulmonary embolism/deep vein thrombosis.
- Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.
- 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 (QTcF interval \> 450 milliseconds, QRS interval \> 120 milliseconds, and PR interval \> 220 milliseconds).
- Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
- Hemoglobin level, WBC count, platelet count, or absolute neutrophil count below the laboratory lower limit of normal at screening or at check-in, confirmed by repeat testing and clinically significant in the opinion of the investigator.
- Hepatic transaminase (ALT and AST), ALP, or total bilirubin levels \> 1.25 × the laboratory-defined ULN at screening or at check-in, confirmed by repeat testing (except participants with Gilbert disease, for which total bilirubin must be ≤ 2.0 × ULN).
- History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or prostate cancer.
- Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy) that could affect the absorption of study drug, with the exception of appendectomy.
- Any major surgery within 12 weeks of screening.
- Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only).
- Blood transfusion within 4 weeks of check-in.
- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nucleus Network Pty Ltd
Melbourne, Victoria, 03004, Australia
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Incyte Medical
Incyte Corporation
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
January 10, 2024
First Posted
January 19, 2024
Study Start
March 14, 2024
Primary Completion
August 19, 2025
Study Completion
August 19, 2025
Last Updated
October 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share