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Trial record 12 of 82699 for:    subjects

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

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.

Condition or disease Intervention/treatment Phase
Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects Drug: TD-3504 Drug: 15N2-tofacitinib Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 4, 2017
Actual Primary Completion Date : November 8, 2017
Actual Study Completion Date : November 8, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tofacitinib

Arm Intervention/treatment
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.
Drug: TD-3504
TD-3504

Drug: 15N2-tofacitinib
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.
Drug: TD-3504
TD-3504

Drug: 15N2-tofacitinib
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.
Drug: TD-3504
TD-3504

Drug: 15N2-tofacitinib
15N2-tofacitinib

Placebo Comparator: Placebo
6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose.
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Tofacitinib relative bioavailability by Cmax comparison [ Time Frame: Day 1 ]
    To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103412


Locations
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United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Brian C. Ferslew, PharmD, PhD Theravance Biopharma, US, Inc.

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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT03103412     History of Changes
Other Study ID Numbers: 0146
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theravance Biopharma:
Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action