Back to resultsTD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
Primary Purpose
Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TD-3504
15N2-tofacitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects focused on measuring Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
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
Sites / Locations
- Anaheim Clinical Trials, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
TD-3504 Low-Dose
TD-3504 Mid-Dose
TD-3504 High-Dose
Placebo
Arm 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.
6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose.
Outcomes
Primary Outcome Measures
Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events
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
Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values
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
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
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
To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Systemic Cmax of tofacitinib
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
To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Systemic Cmax of 15N2-tofacitinib
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
To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Tofacitinib relative bioavailability by Cmax comparison
To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03103412
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
November 8, 2017 (Actual)
Study Completion Date
November 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
Keywords
Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TD-3504 Low-Dose
Arm Type
Experimental
Arm 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.
Arm Title
TD-3504 Mid-Dose
Arm Type
Experimental
Arm Description
6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
Arm Title
TD-3504 High-Dose
Arm Type
Experimental
Arm Description
6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose.
Intervention Type
Drug
Intervention Name(s)
TD-3504
Intervention Description
TD-3504
Intervention Type
Drug
Intervention Name(s)
15N2-tofacitinib
Intervention Description
15N2-tofacitinib
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events
Description
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.
Time Frame
Day 1 through Day 8
Secondary Outcome Measure Information:
Title
Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values
Description
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.
Time Frame
Day 1 through Day 8
Title
Systemic area under the curve of TD-3504
Description
To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Time Frame
Day 1 through Day 4
Title
Systemic Cmax of TD-3504
Description
To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Time Frame
Day 1
Title
Systemic area under the curve of tofacitinib
Description
To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Time Frame
Day 1 through Day 4
Title
Systemic Cmax of tofacitinib
Description
To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Time Frame
Day 1
Title
Systemic area under the curve of 15N2-tofacitinib
Description
To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Time Frame
Day 1 through Day 4
Title
Systemic Cmax of 15N2-tofacitinib
Description
To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Time Frame
Day 1
Title
Tofacitinib relative bioavailability by area under the curve comparison
Description
To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Time Frame
Day 1 through Day 4
Title
Tofacitinib relative bioavailability by Cmax comparison
Description
To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Learn more about this trial
TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
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