AzTrials
AzTrials

Healthy ParticipantsPhase 1NCT06213818

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participant

A Phase 1 study testing INCB160058, Esomeprazole and Famotidine in people with Healthy Participants, run by Incyte Corporation at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
INCB160058, Esomeprazole and Famotidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
137 participants
Where
1 siteAustralia
Study dates
14 Mar 2024to 19 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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).
Show all 32Show fewer
  • 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.
  • Positive test for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.
  • Note: Participants whose results are compatible with prior immunization or immunity due to infection for hepatitis B may be included at the discretion of the investigator.
  • Regular alcohol consumption > 21 units per week (1 unit = ½ pint beer or a 25-mL shot of 40% spirit, 1.5 to 2 units = 125-mL glass of wine, depending on type).
  • Positive urine or breath test for ethanol or positive urine or serum 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 protocol.
  • 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 (refer to the Drug Interaction Database for prohibited drugs).
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
  • Known hypersensitivity or severe reaction to INCB160058 or any excipients of INCB160058 (refer to the IB).
  • 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.
  • Use of tobacco- or nicotine-containing products within 1 month of screening.
  • Use of prescription drugs (including oral, implantable, transdermal, injectable, intravaginal, or hormonal intrauterine contraceptives) or topical steroids within 14 days prior to study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) within 7 days prior to study drug administration and during the study.
  • Note: Occasional use of acetaminophen (see Section 6.6.1) is permitted during the study.
  • Women who are pregnant or breastfeeding.
  • eGFR < 90 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration formula.
  • Any history of hypersensitivity or intolerance to esomeprazole or any other PPI, or to famotidine or any other H2 antagonist.
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Nucleus Network Pty Ltd

    Melbourne, Victoria, 03004

Other trials in Australia

About this study

Official title: 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

This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participants.

Being tested
INCB160058, Placebo, Esomeprazole, Famotidine
Keywords
INCB160058

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCB160058Drug

    Oral; Immediate release solid tablet

  • PlaceboDrug

    Oral; Tablet

  • EsomeprazoleDrug

    Oral; Delayed-release capsule or tablet

  • FamotidineDrug

    Oral; Tablet

Study groups in NCT06213818
Study groupRoleWhat they receive
Cohort 1: DoseExperimentalINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Receives: Drug: INCB160058; Drug: Placebo
Cohort 2: DoseExperimentalINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Receives: Drug: INCB160058; Drug: Placebo
Cohort 3: DoseExperimentalINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Receives: Drug: INCB160058; Drug: Placebo
Cohort 4: DoseExperimentalINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Receives: Drug: INCB160058; Drug: Placebo
Cohort 5: DoseExperimentalINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Receives: Drug: INCB160058; Drug: Placebo
Cohort 6: Dose Treatment AExperimentalINCB160058 will be administered at protocol defined dose after an overnight fast.
Receives: Drug: INCB160058
Cohort 6: Dose Treatment BExperimentalINCB160058 will be administered at protocol defined dose after a high-fat, high-calorie meal.
Receives: Drug: INCB160058
Cohort 7: DoseExperimentalINCB160058 and esomeprazole will be administered at protocol defined schedule and dose.
Receives: Drug: INCB160058; Drug: Esomeprazole
Cohort 8: DoseExperimentalINCB160058 will be administered at protocol defined dose after an overnight fast.
Receives: Drug: INCB160058
Cohort 9: DoseExperimentalINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Receives: Drug: INCB160058; Drug: Placebo
Cohort 10: Dose Treatment AExperimentalINCB160058 will be administered at protocol defined dose after an overnight fast.
Receives: Drug: INCB160058
Cohort 10: Dose Treatment BExperimentalINCB160058 will be administered at protocol defined dose after a high-fat, high-calorie meal.
Receives: Drug: INCB160058
Cohort 11: DoseExperimentalINCB160058 and esomeprazole will be administered at protocol defined schedule and dose.
Receives: Drug: INCB160058; Drug: Esomeprazole
Cohort 12: DoseExperimentalINCB160058 and famotidine will be administered at protocol defined schedule and dose.
Receives: Drug: INCB160058; Drug: Famotidine
Cohort 13: DoseExperimentalINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Receives: Drug: INCB160058; Drug: Placebo
Cohort 14: DoseExperimentalINCB160058 and famotidine will be administered at protocol defined schedule and dose.
Receives: Drug: INCB160058; Drug: Famotidine
Cohort 15: DoseExperimentalINCB160058 or placebo will be administered at protocol defined dose after an overnight fast.
Receives: Drug: INCB160058; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Day 28

  2. INCB160058 pharmacokinetic (PK) when administered as solid tablets in Plasma

    INCB160058 concentration in plasma.

    Measured: Up to Day 5

  3. INCB160058 pharmacokinetic (PK) when administered as a soft gel capsule in Plasma

    INCB160058 concentration in plasma.

    Measured: Up to Day 5

  4. INCB160058 pharmacokinetic (PK) when administered as ASD tablets in Plasma

    INCB160058 concentration in plasma.

    Measured: Up to Day 5

  5. INCB160058 pharmacokinetic (PK) in Plasma to determine the effect of food administered as solid tablets

    INCB160058 concentration in plasma.

    Measured: Up to Day 12

  6. INCB160058 pharmacokinetic (PK) in Plasma to determine the effect of food administered as ASD tablets

    INCB160058 concentration in plasma.

    Measured: Up to Day 12

  7. INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of esomeprazole administered as solid tablets

    INCB160058 concentration in plasma.

    Measured: Up to Day 14

  8. INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of esomeprazole administered as ASD tablets

    INCB160058 concentration in plasma.

    Measured: Up to Day 14

  9. INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of famotidine administered as solid tablets

    INCB160058 concentration in plasma.

    Measured: Up to Day 14

  10. INCB160058 pharmacokinetic (PK) in Plasma to assess the effect of famotidine administered as ASD tablets

    INCB160058 concentration in plasma.

    Measured: Up to Day 14

Secondary outcomes (2)

  1. Additional INCB160058 pharmacokinetic (PK) in Plasma

    Additional INCB160058 concentration in plasma.

    Measured: Up to Day 14

  2. INCB160058 pharmacokinetic (PK) in Urine

    INCB160058 concentration in urine.

    Measured: Up to Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start14 Mar 2024
  3. Primary completion19 Aug 2025
  4. Study completion19 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06213818
Sponsor's protocol ID
INCB160058-102
Status last verified
Oct 2025
First submitted
10 Jan 2024
Last updated
14 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCB160058, Esomeprazole and Famotidine in people with Healthy Participants, run by Incyte Corporation at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Treatment Emergent Adverse Events (TEAEs) (time frame: Up to Day 28). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06213818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in