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

Theravance Biopharma

Status and phase: Completed; Phase 1

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

Treatments: Drug: Placebo; Drug: TD-3504; Drug: 15N2-tofacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03103412

0146

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 4 patient groups, including a placebo group

TD-3504 Low-Dose

Experimental group

Description:

6 healthy subjects and 6 ulcerative colitis subjects will be randomized to receive low-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.

Treatment:

Drug: TD-3504

Drug: 15N2-tofacitinib

TD-3504 Mid-Dose

Experimental group

Description:

6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.

Treatment:

Drug: TD-3504

Drug: 15N2-tofacitinib

TD-3504 High-Dose

Experimental group

Description:

6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.

Treatment:

Drug: TD-3504

Drug: 15N2-tofacitinib

Placebo

Placebo Comparator group

Description:

6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose.

Treatment:

Drug: Placebo