Primary Outcome
Open
Total recovery of radioactivity from urine and feces.
Timeframe: Approximately 2 weeks
Percentage of total radioactive dose in Plasma, Urinary and Fecal Excretion
Timeframe: Up to approximately 2 months
Other
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB086550
Incyte Study ID:
INCB 86550-106
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Study Complete
Clinical Study Purpose
To evaluate the absorption, metabolism, and excretion of 86550-106 in healthy males.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Jan 2022 - Mar 2022
TYPE
Interventional
PHASE
Phase 1
SEX
Male only
AGE
35 - 55 Years
ACCEPTS HEALTHY VOLUNTEERS
Yes
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Ability to comprehend and willingness to sign a written ICF for the study.
- Male healthy adult participants aged 35 to 55 years, inclusive, at the time of screening.
Exclusion Criteria
- History of clinically significant respiratory, renal, gastrointestinal, endocrine,
- hematopoietic, psychiatric, and/or neurological disease.
Clinical Study Locations
Location
Status
Location
COVANCE LEEDS CRU
LEEDS, United Kingdom, LS2 9LH
Status
Active, not recruiting
Protocol Summary
Incyte Study ID:
INCB 86550-106
Primary Purpose:
Treatment
Allocation:
N/A
Study Design:
Single Group Assignment
Masking:
None (Open Label)
Interventions:
Drug
Enrollment:
7
Secondary Outcome
Open
PK for plasma INCB086550: Cmax
Timeframe: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: tmax
Timeframe: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: AUC0-t
Timeframe: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: AUC0-∞
Timeframe: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: t½
Timeframe: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: λz
Timeframe: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: CL/F
Timeframe: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: Vz/F
Timeframe: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for Urine INCB086550: Ae
Timeframe: Pre dose and Post dose daily up to day 11, until study discharge
PK for urine INCB086550: CLR
Timeframe: Pre dose and Post dose daily up to day 11, until study discharge
PK for Urine INCB086550: fe
Timeframe: Pre dose and Post dose daily up to day 11, until study discharge
PK for whole blood and plasma total radioactivity: Cmax
Timeframe: Pre dose and poste dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: tmax
Timeframe: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: t½
Timeframe: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: AUC0-t
Timeframe: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: AUC0-∞
Timeframe: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
Incidence of AEs, ECGs, vital signs, and clinical laboratory evaluation.
Timeframe: up to approximately 3 months