This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. The relative bioavailability of tofacitinib released from TD-3504 compared to co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events
To assess the safety \& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing the number, severity, and type of treatment related adverse events.
Time frame: Day 1 through Day 8
Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values
To assess the safety \& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing treatment related changes safety laboratory values.
Time frame: Day 1 through Day 8
Systemic area under the curve of TD-3504
To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Time frame: Day 1 through Day 4
Systemic Cmax of TD-3504
To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Time frame: Day 1
Systemic area under the curve of tofacitinib
To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Time frame: Day 1 through Day 4
Systemic Cmax of tofacitinib
To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
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Time frame: Day 1
Systemic area under the curve of 15N2-tofacitinib
To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Time frame: Day 1 through Day 4
Systemic Cmax of 15N2-tofacitinib
To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Time frame: Day 1
Tofacitinib relative bioavailability by area under the curve comparison
To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Time frame: Day 1 through Day 4
Tofacitinib relative bioavailability by Cmax comparison
To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Time frame: Day 1