The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of increasing oral doses of INCB106385 in healthy adult participants, and the effect of food on pharmacokinetics, as well as drug interaction with a Proton Pump Inhibitor (PPI) esomeprazole.
- Conditions
- Solid TumorsCancer - Other cancer types
- Registration Number
- ACTRN12620000630910
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 84
1. Male or female healthy adult participants aged 18 to 55 years
2. BMI between 18.0 and 30.0 kg/m2, inclusive. Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor’s approval.
3. Willingness to avoid pregnancy or fathering children.
History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
2.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
3.Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy) that could affect the absorption of study drug except that appendectomy will be allowed.
4.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 only).
5.History of alcoholism within 3 months of screening.
6.Positive urine, blood, 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.
7.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.
8.History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
9.Use of tobacco- or nicotine-containing products within 1 months of screening.
10.Women who are pregnant or breastfeeding.
11.Any history of hypersensitivity or intolerance to esomeprazole or any other Proton Pump Inhibitor
Reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method