Clinical trial NCT03103412: TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
Keywords: Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2017-04-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events
timeFrame: Day 1 through Day 8
Secondary outcomes:
measure: Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values
timeFrame: Day 1 through Day 8
measure: Systemic area under the curve of TD-3504
timeFrame: Day 1 through Day 4
measure: Systemic Cmax of TD-3504
timeFrame: Day 1
measure: Systemic area under the curve of tofacitinib
timeFrame: Day 1 through Day 4
measure: Systemic Cmax of tofacitinib
timeFrame: Day 1
measure: Systemic area under the curve of 15N2-tofacitinib
timeFrame: Day 1 through Day 4
measure: Systemic Cmax of 15N2-tofacitinib
timeFrame: Day 1
measure: Tofacitinib relative bioavailability by area under the curve comparison
timeFrame: Day 1 through Day 4
measure: Tofacitinib relative bioavailability by Cmax comparison
timeFrame: Day 1
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: