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

Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects Clinical Trial

Official title: Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
• Colitis
• Colitis, Ulcerative
• Ulcer

• NCT number: NCT03103412
• Study type: Interventional
• Source: Theravance Biopharma
• Status: Completed
• Phase: Phase 1
• Start date: May 4, 2017
• Completion date: November 8, 2017