TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
- Conditions
- Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
- Interventions
- Registration Number
- NCT03103412
- Lead Sponsor
- Theravance Biopharma
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TD-3504 Low-Dose 15N2-tofacitinib 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. TD-3504 Mid-Dose TD-3504 6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. TD-3504 Low-Dose TD-3504 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. TD-3504 Mid-Dose 15N2-tofacitinib 6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. TD-3504 High-Dose TD-3504 6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. TD-3504 High-Dose 15N2-tofacitinib 6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. Placebo Placebo 6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose.
- Primary Outcome Measures
Name Time Method Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events Day 1 through Day 8 To assess the safety \& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing the number, severity, and type of treatment related adverse events.
- Secondary Outcome Measures
Name Time Method Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values Day 1 through Day 8 To assess the safety \& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing treatment related changes safety laboratory values.
Systemic area under the curve of TD-3504 Day 1 through Day 4 To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Systemic Cmax of TD-3504 Day 1 To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Systemic area under the curve of tofacitinib Day 1 through Day 4 To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Systemic Cmax of tofacitinib Day 1 To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Systemic area under the curve of 15N2-tofacitinib Day 1 through Day 4 To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Systemic Cmax of 15N2-tofacitinib Day 1 To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Tofacitinib relative bioavailability by area under the curve comparison Day 1 through Day 4 To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Tofacitinib relative bioavailability by Cmax comparison Day 1 To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Trial Locations
- Locations (1)
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States