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Trial record 4 of 10 for:    TD-1473

SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02657122
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Tracking Information
First Submitted Date  ICMJE November 25, 2015
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date January 19, 2021
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
To evaluate the safety and tolerability of SAD and MAD of TD-1473 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs [ Time Frame: Day 1 through Day 8 (SAD) or 21 (MAD) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • Area under curve (AUC) in plasma, urine and feces [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  • Cmax in plasma, urine and feces [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  • Tmax in plasma, urine and feces [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  • Terminal elimination half-life (t1/2) in plasma, urine and feces [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  • Amount excreted in urine (Aeu) [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  • Amount excreted in feces (Aef) [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  • AUC in plasma, urine and feces [ Time Frame: Day 1 through Day 17-19 (MAD) ]
  • Cmax in plasma, urine and feces [ Time Frame: Day 1 through Day 17-19 (MAD) ]
  • Tmax in plasma, urine and feces [ Time Frame: Day 1 through Day 17-19 (MAD) ]
  • t1/2 in plasma, urine and feces [ Time Frame: Day 1 through Day 17-19 (MAD) ]
  • Aeu [ Time Frame: Day 1 through Day 17-19 (MAD) ]
  • Aef [ Time Frame: Day 1 through Day 17-19 (MAD) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects
Official Title  ICMJE A Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Subjects
Brief Summary The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: TD-1473 for SAD
    SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.
  • Drug: Placebo for SAD
    SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.
  • Drug: TD-1473 for MAD
    MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.
  • Drug: Placebo for MAD
    MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.
Study Arms  ICMJE
  • Experimental: TD-1473 for SAD
    6 of out 8 subjects per cohort will be randomized to receive TD-1473
    Intervention: Drug: TD-1473 for SAD
  • Placebo Comparator: Placebo for SAD
    2 of out 8 subjects per cohort will be randomized to receive placebo
    Intervention: Drug: Placebo for SAD
  • Experimental: TD-1473 for MAD
    6 of out 8 subjects per cohort will be randomized to receive TD-1473
    Intervention: Drug: TD-1473 for MAD
  • Placebo Comparator: Placebo for MAD
    2 of out 8 subjects per cohort will be randomized to receive placebo
    Intervention: Drug: Placebo for MAD
Publications * Sandborn WJ, Nguyen DD, Beattie DT, Brassil P, Krey W, Woo J, Situ E, Sana R, Sandvik E, Pulido-Rios MT, Bhandari R, Leighton JA, Ganeshappa R, Boyle DL, Abhyankar B, Kleinschek MA, Graham RA, Panes J. Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Colitis: A Translational Medicine Programme. J Crohns Colitis. 2020 Sep 16;14(9):1202-1213. doi: 10.1093/ecco-jcc/jjaa049.

*   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: January 13, 2016)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male or female 19 to 55 years old
  • Willing and able to give informed consent
  • Body Mass Index (BMI) 18 to 30 kg/m2
  • 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
  • Additional inclusion criteria apply

Exclusion Criteria:

  • Positive for hepatitis A, B, or C, HIV, or tuberculosis (TB)
  • Clinically significant abnormalities in baseline results of laboratory evaluations
  • Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
  • 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)
  • 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.
  • Additional exclusion criteria apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 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 NCT02657122
Other Study ID Numbers  ICMJE 0140
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Current Responsible Party Theravance Biopharma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Theravance Biopharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Theravance Biopharma
PRS Account Theravance Biopharma
Verification Date January 2021

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