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Trial record 3 of 10 for:    TD-1473

TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male 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: NCT03408470
Recruitment Status : Completed
First Posted : January 24, 2018
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Tracking Information
First Submitted Date  ICMJE January 12, 2018
First Posted Date  ICMJE January 24, 2018
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE January 31, 2018
Actual Primary Completion Date February 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • Maximum observed concentration (Cmax) in Plasma [ Time Frame: Up to 15 days ]
  • Time to maximum observed concentration (tmax) in Plasma [ Time Frame: Up to 15 days ]
  • Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma [ Time Frame: Up to 15 days ]
  • Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma [ Time Frame: Up to 15 days ]
  • Apparent terminal elimination half-life (t1/2) in Plasma [ Time Frame: Up to 15 days ]
  • Apparent clearance (Cl/F) in Plasma [ Time Frame: Up to 15 days ]
  • Apparent volume of distribution (Vz/F) in Plasma [ Time Frame: Up to 15 days ]
  • Absolute bioavailability (%F) in Plasma [ Time Frame: Up to 15 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • Amount excreted in urine (Aeu) over the sampling interval in Urine [ Time Frame: Up to 15 days ]
  • Renal clearance (CLr) in Urine [ Time Frame: Up to 15 days ]
  • The percent excreted in urine (%Feu) in Urine [ Time Frame: Up to 15 days ]
  • Amount excreted in feces (Aef) over the sampling interval in Feces [ Time Frame: Up to 15 days ]
  • The percent excreted in feces (%Fef) [ Time Frame: Up to 15 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 22, 2018)
  • Metabolites in Plasma [ Time Frame: Up to 15 days ]
    TD 1473 metabolite profiling will be performed in plasma containing sufficient amounts of radioactivity
  • Metabolites in Urine [ Time Frame: Up to 15 days ]
    TD 1473 metabolite profiling will be performed in urine containing sufficient amounts of radioactivity
  • Metabolites in Feces [ Time Frame: Up to 15 days ]
    TD-1473 metabolite profiling will be performed in feces containing sufficient amounts of radioactivity
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects
Official Title  ICMJE A 2-Cohort Study to Evaluate the Absolute Bioavailability, Absorption, Distribution, Metabolism and Excretion of TD-1473 Following an Intravenous and an Oral Dose of [14C]-TD-1473 in Healthy Male Subjects
Brief Summary This is an open-label, 2-cohort study to evaluate the absolute bioavailability, absorption, distribution, metabolism and excretion of TD-1473 in healthy male subjects. Subjects in cohort 1 will receive a single oral dose of TD-1473 and a single intravenous bolus dose of [14C]-TD-1473. Subjects in cohort 2 will receive a single oral dose of [14C]-TD-1473 only.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Intestinal Disorders
  • Bowel Diseases, Inflammatory
Intervention  ICMJE
  • Drug: TD-1473 oral capsule
    (Intervention description included in arm description)
  • Drug: [14C]-TD-1473 IV bolus
    (Intervention description included in arm description)
  • Drug: [14C]-TD-1473 Oral Capsule
    (Intervention description included in arm description)
Study Arms  ICMJE
  • Experimental: TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus
    Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473
    Interventions:
    • Drug: TD-1473 oral capsule
    • Drug: [14C]-TD-1473 IV bolus
  • Experimental: [14C]-TD-1473 Oral Capsule
    Cohort 2 - One oral dose
    Intervention: Drug: [14C]-TD-1473 Oral Capsule
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: January 22, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 21, 2018
Actual Primary Completion Date February 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is a healthy, nonsmoking male, 19 to 55 years old, inclusive
  • Subject has a body mass index (BMI) 19 to 32 kg/m2, inclusive, and weighs at least 50 kg
  • Subject is healthy as determined by the PI or designee based on medical history and physical examination performed at Screening and Day -1
  • Additional inclusion criteria apply

Exclusion Criteria:

  • Subject has any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas])
  • Subject has a known hypersensitivity towards medications similar to TD 1473 or excipients contained in TD 1473
  • Subject regularly works with ionizing radiation or radioactive material
  • Subject has been exposed to ionizing radiations, within 1 year prior to the start of the study, as external irradiation (i.e., radiological examination including CT scan, excluding dental radiography) or internal radiation (i.e., diagnostic nuclear medicine procedure) or have participated in a radiolabeled study in the last 12 months
  • Subject, who, for any reason, is deemed by the PI or designee or Sponsor to be inappropriate for this study or have any condition which would confound or interfere with the evaluation of the safety, tolerability, and PK of the investigational drug or prevent compliance with the study protocol
  • Additional exclusion criteria apply
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Males only
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 NCT03408470
Other Study ID Numbers  ICMJE 0152
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: No
Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Responsible Party Theravance Biopharma
Study Sponsor  ICMJE Theravance Biopharma
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