None listed
Conditions
Brief summary
The purpose of this study is to assess the safety, tolerability of the drug INCB106385 and assess how this drug acts in the body with and without food in increasing doses and assess how this drug interacts with esomeprazole, a PPI. 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. All participants will provide blood and urine samples. Participants in this study will be randomized (by chance) in each of the 7 cohort. In Cohorts 1-5, all participants will either receive a single dose of the drug or placebo (orally in a fasted condition (no food). In Cohort 6 all participants will be randomly assigned to treatment A or treatment B groups and then crossed over to the other treatment group (A or B) after a washout of 7 days. Participants in treatment A group will be dosed after fasting of 8 hrs. Participants in treatment B group will be fed a high-fat calorie meal before 30 min of dose administration. In Cohort 7 all participants will be dosed with drug on day 1 and dosed with esomeprazole on day 5-9 and on day 10 participants will be dosed with drug and esomeprazole. It is hoped this research will provide information as to how this drug acts in the body in fed and fasted conditions and the impact of changes in gut pH. Results from the study will affect how patients with cancer take the drug in regards to their meals.
Interventions
INCB106385 is an oral tablet administered after a fast of 8 hrs. in cohorts 1 through 5 (dose escalation cohorts). In Cohort 6 (food effect cohort) participants will be randomly assigned to treatment A or treatment B groups and then crossed over to the other treatment group (A or B) after a washout of 7 days. Participants in treatment A group will be dosed after fasting of 8 hrs. Participants in treatment B group will be fed a high-fat calorie meal before 30 min of dose administration. Participa
INCB106385 is an oral tablet administered after a fast of 8 hrs. in cohorts 1 through 5 (dose escalation cohorts). In Cohort 6 (food effect cohort) participants will be randomly assigned to treatment A or treatment B groups and then crossed over to the other treatment group (A or B) after a washout of 7 days. Participants in treatment A group will be dosed after fasting of 8 hrs. Participants in treatment B group will be fed a high-fat calorie meal before 30 min of dose administration. Participants will be admitted to the clinic on the day -1 before study drug administration and confined through 96 hours after the dosing. In Cohort 6 participants will return on Day 7 for admission and receive another dose of the drug on Day 8 and be confined through 96 hours after dosing. In Cohort 7, drug interaction with esomeprazole (a proton pump inhibitor, PPI) will be evaluated. All participants will receive the same dose of INCB106385 in the fasted state alone or with esomeprazole. Cohort 1 - up to 5 mg of INCB106385 or Placebo as a single dose administered orally in a fasted condition Cohort 2 - up to15 mg of INCB106385 or Placebo as a single dose administered orally in a fasted condition Cohort 3 - up to 40 mg of INCB106385 or Placebo as a single dose administered orally in a fasted condition Cohort 4 - up to 100 mg of INCB106385 or Placebo as a single dose administered orally in a fasted condition Cohort 5 -up to 200 mg of INCB106385 or Placebo as a single dose administered orally in a fasted condition Cohort 6 - up to 100 mg of INCB106385 in Fasted or Fed conditions as a single dose administered orally Cohort 7 - up to 100 mg of INCB106385 administered orally in Fasted condition on Day 1 and 40 mg of esomeprazole is administered orally on days 5 through 9 under fed conditions and a combination of INCB106385 (100 mg) and esomeprazole (40 mg) administered in fasted conditions on day 10.
Sponsors
Incyte Corporation
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
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
Outcome results
None listed