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

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ClinicalTrials.gov Identifier: NCT03103412
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Tracking Information
First Submitted Date  ICMJE March 24, 2017
First Posted Date  ICMJE April 6, 2017
Last Update Posted Date December 5, 2017
Actual Study Start Date  ICMJE May 4, 2017
Actual Primary Completion Date November 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
To assess safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events [ Time Frame: 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.
Change History Complete list of historical versions of study NCT03103412 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 ]
    To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • To assess the safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values [ Time Frame: 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.
  • To assess the systemic area under the curve of TD-3504 [ Time Frame: 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.
  • To assess the systemic Cmax of TD-3504 [ Time Frame: Day 1 ]
    To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
  • To assess the systemic area under the curve of tofacitinib [ Time Frame: Day 1 through Day 4 ]
    To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
  • To assess the systemic Cmax of tofacitinib [ Time Frame: Day 1 ]
    To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
  • To assess the systemic area under the curve of 15N2-tofacitinib [ Time Frame: Day 1 through Day 4 ]
    To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
  • To assess the systemic Cmax of 15N2-tofacitinib [ Time Frame: Day 1 ]
    To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
  • To assess the tofacitinib relative bioavailability by area under the curve comparison [ Time Frame: Day 1 through Day 4 ]
    To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
  • To assess the tofacitinib relative bioavailability by Cmax comparison [ Time Frame: Day 1 ]
    To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
Intervention  ICMJE
  • Drug: TD-3504
    TD-3504
  • Drug: 15N2-tofacitinib
    15N2-tofacitinib
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: TD-3504 Low-Dose
    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.
    Interventions:
    • Drug: TD-3504
    • Drug: 15N2-tofacitinib
  • Experimental: TD-3504 Mid-Dose
    6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
    Interventions:
    • Drug: TD-3504
    • Drug: 15N2-tofacitinib
  • Experimental: TD-3504 High-Dose
    6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
    Interventions:
    • Drug: TD-3504
    • Drug: 15N2-tofacitinib
  • Placebo Comparator: Placebo
    6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2017)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 8, 2017
Actual Primary Completion Date November 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03103412
Other Study ID Numbers  ICMJE 0146
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Theravance Biopharma
Study Sponsor  ICMJE Theravance Biopharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Brian C. Ferslew, PharmD, PhD Theravance Biopharma, US, Inc.
PRS Account Theravance Biopharma
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP