None listed
Conditions
Brief summary
The purpose of this study is to assess the safety, tolerability of the drug INCB086550 and assess how this drug acts in the body with and without food and in combination with other drugs. who is it for? You may be eligible for this study if you are a male or female, aged 18 to 55, and you are in good health with no existing conditions. Study Details In Cohort 1 all participants will receive a single dose of the drug (orally in a fasted (no food) or fed (med calorie food) condition in Periods 1 and 2 by random assignment. In Cohort 2 through 5 subjects will be dosed with INCB086550 in combination with other drugs specified earlier. It is hoped this research will provide information as to how this drug acts in the body in fed and fasted conditions and in combination with other drugs, results from the study will affect how patients with cancer use this medication
Interventions
INCB086550 is an oral tablet administered in healthy adult participants in combination with food, esomeprazole, famotidine, itraconazole and rifampin. In Cohort 1, all participants will receive the same dose of INCB086550 in both a fasted and a fed state. In Cohort 2-5, all participants will receive the same dose of INCB086550 alone or with interacting drug in a fasted state.
Cohort 1 - 400 mg of INCB086550 as a single dose administered orally in a fasted or fed condition
Cohort 2 - 400 mg
INCB086550 is an oral tablet administered in healthy adult participants in combination with food, esomeprazole, famotidine, itraconazole and rifampin. In Cohort 1, all participants will receive the same dose of INCB086550 in both a fasted and a fed state. In Cohort 2-5, all participants will receive the same dose of INCB086550 alone or with interacting drug in a fasted state. Cohort 1 - 400 mg of INCB086550 as a single dose administered orally in a fasted or fed condition Cohort 2 - 400 mg of INCB086550 as a single dose administered orally on Day 1 and 40 mg of Esomeprazole is administered orally on days 5 through 9 and a combination of INCB086550 (400 mg) and Esomeprazole (40 mg) administered on day 8 in fasted conditions. Cohort 3 - 400 mg of INCB086550 as a single dose administered orally on Day 1 and 20 mg of Famotidine is administered orally on days 5 through 7 and a combination of INCB086550 (400 mg) and Famotidine (20 mg) administered on day 8 in fasted conditions. Cohort 4 - 200 mg of INCB086550 as a single dose administered orally on Day 1 and 200 mg of Itraconazole is administered orally on days 4 through 7 and a combination of INCB086550 (400 mg) and Itraconazole (200 mg) administered on day 8 in fasted conditions. Itraconazole (200 mg) is administered on days 9 through 11 in fed state. Cohort 5 - 400 mg of INCB086550 as a single dose administered orally on Day 1 and 600 mg of Rifampin is administered orally on days 4 through 10 and a combination of INCB086550 (400 mg) and Rifampin (600 mg) administered on day 11 in fasted conditions. Rifampin (600 mg) is administered on day 12 in fed state. The study participants are in-house for the duration of the trial, therefore, all dose administrations is managed by the site staff. The site pharmacist will maintain drug accountability logs that record the dose administration for each study participant
Sponsors
Incyte Corporation
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Male or female healthy adult participants aged 18 to 55 years. Body mass index between 18.0 and 30.5 kg/m2, inclusive. No clinically significant findings on screening evaluations (clinical, laboratory, and ECG). Ability to swallow and retain oral medication. Willingness to avoid pregnancy or fathering children.
Exclusion criteria
1.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
Outcome results
None listed