NCT03103412

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	TD-3504	TD-3504
DRUG	15N2-tofacitinib	15N2-tofacitinib
DRUG	Placebo	Placebo

Timeline

• Start date: 2017-05-04
• Primary completion: 2017-11-08
• Completion: 2017-11-08
• First posted: 2017-04-06
• Last updated: 2021-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study