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

Completed · Phase 1 · Has a placebo group

Conditions studied: Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects

In brief

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.

Key facts

Study ID

NCT03103412

Run by

Theravance Biopharma

People needed

32

Starts

2017-05-04

Expected to finish

2017-11-08

Last updated by the study team

2021-01-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female between 18 to 55 years old
• Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
• Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
• Body Mass Index (BMI) 18 to 32 kg/m2
• Willing and able to give informed consent
• Additional inclusion criteria apply
• Inclusion Criteria for Ulcerative Colitis (UC) subjects:
• Subject has a history of UC
• Subject is either not taking any medication for UC or has been taking a stable dose of ulcerative colitis medications for ≥ 14 days
• Additional inclusion criteria apply

You may not qualify if…

• Is positive for hepatitis A, B or C, HIV or tuberculosis
• Has clinically significant abnormalities in baseline laboratory evaluations
• Subject has a clinically significant abnormal electrocardiogram (ECG)
• Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening (or within 60 days prior to screening if investigational drug was a biologic, or is currently participating in another trial of an investigational drug (or medical device)
• Additional exclusion criteria apply
• Exclusion Criteria for Healthy Subjects:
• Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy or standard daily multivitamin.
• Additional exclusion criteria apply

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States

Full record on ClinicalTrials.gov

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