The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of increasing oral doses of INCB099318 in healthy adult participants, and the effect of food on pharmacokinetics.
- Conditions
- Solid TumorsCancer - Other cancer types
- Registration Number
- ACTRN12620000118909
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 72
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of treatment-emergent adverse events with INCB099318. <br>As this is the first clinical study of INCB099318, the safety profile in humans has not been established, possible symptoms or adverse effects that could occur may be immune-related effects such as inflammation of the skin or mucosa (for example, itching, redness, rash), inflammation of the lungs, inflammation of the bowels (for example, diarrhea), endocrine (hormone) dysfunction, liver injury, and fatigue or lack of energy. AE's will be assessed by clinical examination and self reporting.[Baseline to 30 days after last dose ];Pharmacokinetic (PK) evaluation of INCB099318 (Cmax, Tmax, AUC0-t and AUC 0-inf) in the fasted state in plasma samples[0h (pre dose), 0.5,1,2,4,6,8,12,16,24,36,48, 72, and 96h post dose. ];Pharmacokinetic (PK) evaluation of INCB099318 (Cmax, Tmax, AUC0-t and AUC 0-inf) and to determine the effect of food in plasma samples[0h (pre dose), 0.5,1,2,4,6,8,12,16,24,36,48, 72, and 96h post dose ]
- Secondary Outcome Measures
Name Time Method Additional Pharmacokinetic parameter evaluation in Plasma include<br>t½, CL/F, Vz/F, Lambda-z<br>[0h (pre dose), 0.5,1,2,4,6,8,12,16,24,36,48, 72, and 96h post dose ];Pharmacokinetic evaluation of INCB099318 in Urine include<br>Ae96h and CLR<br>[0-8,8-16,16-24,24-36,36-48,48-72, and 72-96 h post dose. ]