drugset / Trial / NCT03103412

TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)

NCT03103412 ↗

Phase 1 Completed 32 enrolled Theravance Biopharma
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2017-05-04
Primary completion
2017-11-08
Completion
2017-11-08

Drugs

EvaluationDrugModalityDoseRoute
Subject 15N2-tofacitinib Unknown — Oral
Subject TD-3504 Unknown — Oral

Indications