None listed
Conditions
Brief summary
The purpose of this study is to assess the safety, tolerability of the drug INCB099280 and assess how this drug acts in the body with and without food in increasing doses. 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. Participants in this study will be randomized (by chance) in each of the 6 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. Participants will also provide blood and urine samples. It is hoped this research will provide information as to how this drug acts in the body in fed and fasted conditions, results from the study will affect how patients with cancer use this medication.
Interventions
INCB099280 is an oral tablet administered after a fast of 8 hrs. in cohorts 1 through 5. In Cohort 6 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
INCB099280 is an oral tablet administered after a fast of 8 hrs. in cohorts 1 through 5. In Cohort 6 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 confined through 96 hours after dosing. Cohort 1 - 25 mg of INCB099280 or Placebo as a single dose administered orally in a fasted condition Cohort 2 - 75 mg of INCB099280 or Placebo as a single dose administered orally in a fasted condition Cohort 3 - 150 mg of INCB099280 or Placebo as a single dose administered orally in a fasted condition Cohort 4 - 300 mg of INCB099280 or Placebo as a single dose administered orally in a fasted condition Cohort 5 - 450 mg of INCB099280 or Placebo as a single dose administered orally in a fasted condition Cohort 6 - 150mg of INCB099280 in Fasted or Fed conditions as a single dose administered orally
Sponsors
Incyte Corporation
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
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
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.
Outcome results
None listed