Healthy Participants
Conditions
Keywords
INCB161734
Brief summary
This study is conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of \[14C\]-INCB161734 in healthy male participants.
Interventions
DRUGINCB161734
Participants will be administered orally a dose solution consisting of INCB161734 and radiolabeled INCB161734.
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males aged 19 to 55 years (inclusive) at the time of signing the ICF. * Body mass index between 18.0 and 32.0 kg/m2 (inclusive). * Ability to swallow and retain oral medication.
Exclusion criteria
* History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening. * Resting pulse \< 40 bpm or \> 100 bpm, confirmed by repeat testing at screening. * History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant (QTcF interval \> 450 milliseconds \[may increase the risk associated with participating in the study or may confound ECG data analysis\], QRS interval \> 120 milliseconds, and PR interval \> 220 milliseconds). * Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis). * History of irregular bowel movements (eg, irritable bowel syndrome, frequent episodes of diarrhea, or constipation defined by less than 1 bowel movement on average per 2 days) or lactose intolerant. * History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or prostate cancer. * Current or recent (≤ 6 months of screening), clinically significant gastrointestinal disease or surgery or any history of gastrointestinal surgery (including cholecystectomy, excluding appendectomy and uncomplicated hernia repair) that is anticipated to affect the absorption of study treatment. * Any major surgery within ≤ 6 months of screening. * Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only). * Blood transfusion within 4 weeks of check-in. * Positive test for hepatitis B virus, HCV, or HIV. • Note: Participants whose results are compatible with prior immunization or immunity due to infection for hepatitis B may be included at the discretion of the investigator. * History of significant alcohol use within 3 months of screening, defined as regular alcohol consumption \> 21 units per week (1 unit = ½ pint beer or a 25-mL shot of 40% spirit, 1.5 to 2 units = 125-mL glass of wine, depending on type). * Positive urine 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. * Exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or employment in a job requiring radiation exposure monitoring within 12 months prior to check-in. * History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator. * Known hypersensitivity or severe reaction to INCB161734 or any excipients of INCB161734 (refer to the IB). * Use of tobacco- or nicotine-containing products within 1 month of screening. * eGFR \< 90 mL/min/1.73 m2 based on the site's preferred formula at screening. • Note: Assessment of eGFR may be repeated once if outside of the reference range. Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Recovery (Urine + Feces) of the Administered Radioactivity | Up to 2 weeks | Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted. |
| Percentage of total radioactive dose in Plasma, Urinary and Fecal Excretion | Up to 2 weeks | To characterize the metabolic profile and identify circulating and excreted metabolites of INCB161734. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK for plasma INCB123667: Cmax | Up to 2 weeks | Defined as the maximum plasma concentration. |
| PK for plasma INCB123667: tmax | Up to 2 weeks | Defined as the time to reach maximum concentration. |
| PK for plasma INCB123667: AUClast | Up to 2 weeks | Defined as area under the concentration-time profile from time zero to time of the last quantifiable concentration (Clast). |
| PK for plasma INCB123667: AUCinf | Up to 2 weeks | Defined as area under the concentration-time profile extrapolated to time of infinity. |
| PK for plasma INCB123667: t½ | Up to 2 weeks | Defined as terminal-phase half-life. |
| PK for plasma INCB123667: CL/F | Up to 2 weeks | Defined as apparent clearance. |
| PK for plasma INCB123667: Vz/F | Up to 2 weeks | Defined as apparent volume of distribution. |
| PK for urine INCB123667: Ae | Up to 2 weeks | Defined as cumulative amount of drug excreted unchanged in the urine for the entire sampling period. |
| PK for urine INCB123667: CLR | Up to 2 weeks | Defined as renal clearance. |
| PK for urine INCB123667: %fe | Up to 2 weeks | Defined as fraction of drug excreted unchanged in urine. |
| PK for whole blood and plasma total radioactivity: Cmax | Up to 2 weeks | Defined as the maximum plasma concentration. |
| PK for whole blood and plasma total radioactivity: tmax | Up to 2 weeks | Defined as the time to reach maximum concentration. |
| PK for whole blood and plasma total radioactivity: AUClast | Up to 2 weeks | Defined as area under the concentration-time profile from time zero to time of the last quantifiable concentration (Clast). |
| PK for whole blood and plasma total radioactivity: AUCinf | Up to 2 weeks | Defined as area under the concentration-time profile extrapolated to time of infinity. |
| PK for whole blood and plasma total radioactivity: t½ | Up to 2 weeks | Defined as terminal-phase half-life. |
| Treatment Emergent Adverse Events (TEAEs) | Up to approximately 2 months | Adverse events reported for the first time or worsening of a pre-existing event, occurring after study treatment administration. |
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed