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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

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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

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.

Condition or disease Intervention/treatment Phase
Intestinal Disorders Bowel Diseases, Inflammatory Drug: TD-1473 oral capsule Drug: [14C]-TD-1473 IV bolus Drug: [14C]-TD-1473 Oral Capsule Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : January 31, 2018
Actual Primary Completion Date : February 21, 2018
Actual Study Completion Date : February 21, 2018

Arm Intervention/treatment
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
Drug: TD-1473 oral capsule
(Intervention description included in arm description)

Drug: [14C]-TD-1473 IV bolus
(Intervention description included in arm description)

Experimental: [14C]-TD-1473 Oral Capsule
Cohort 2 - One oral dose
Drug: [14C]-TD-1473 Oral Capsule
(Intervention description included in arm description)




Primary Outcome Measures :
  1. Maximum observed concentration (Cmax) in Plasma [ Time Frame: Up to 15 days ]
  2. Time to maximum observed concentration (tmax) in Plasma [ Time Frame: Up to 15 days ]
  3. Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma [ Time Frame: Up to 15 days ]
  4. Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma [ Time Frame: Up to 15 days ]
  5. Apparent terminal elimination half-life (t1/2) in Plasma [ Time Frame: Up to 15 days ]
  6. Apparent clearance (Cl/F) in Plasma [ Time Frame: Up to 15 days ]
  7. Apparent volume of distribution (Vz/F) in Plasma [ Time Frame: Up to 15 days ]
  8. Absolute bioavailability (%F) in Plasma [ Time Frame: Up to 15 days ]

Secondary Outcome Measures :
  1. Amount excreted in urine (Aeu) over the sampling interval in Urine [ Time Frame: Up to 15 days ]
  2. Renal clearance (CLr) in Urine [ Time Frame: Up to 15 days ]
  3. The percent excreted in urine (%Feu) in Urine [ Time Frame: Up to 15 days ]
  4. Amount excreted in feces (Aef) over the sampling interval in Feces [ Time Frame: Up to 15 days ]
  5. The percent excreted in feces (%Fef) [ Time Frame: Up to 15 days ]

Other Outcome Measures:
  1. Metabolites in Plasma [ Time Frame: Up to 15 days ]
    TD 1473 metabolite profiling will be performed in plasma containing sufficient amounts of radioactivity

  2. Metabolites in Urine [ Time Frame: Up to 15 days ]
    TD 1473 metabolite profiling will be performed in urine containing sufficient amounts of radioactivity

  3. Metabolites in Feces [ Time Frame: Up to 15 days ]
    TD-1473 metabolite profiling will be performed in feces containing sufficient amounts of radioactivity



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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males only
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03408470


Locations
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United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma
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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT03408470    
Other Study ID Numbers: 0152
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

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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:
Absolute Bioavailability
ADME
Healthy Normal Males
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis