TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects

• ClinicalTrials.gov Identifier: NCT03408470
• Recruitment Status: Completed
• First Posted: January 24, 2018
• Last Update Posted: January 14, 2021
• Sponsor: Theravance Biopharma
• Information provided by (Responsible Party): Theravance Biopharma

Tracking Information

• First Submitted Date: January 12, 2018
• First Posted Date: January 24, 2018
• Last Update Posted Date: January 14, 2021
• Actual Study Start Date: January 31, 2018
• Actual Primary Completion Date: February 21, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Intestinal Disorders
• Bowel Diseases, Inflammatory

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 22, 2018): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 21, 2018
• Actual Primary Completion Date: February 21, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Males only

• Ages: 19 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03408470
• Other Study ID Numbers: 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

• 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: Theravance Biopharma
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Theravance Biopharma

• PRS Account: Theravance Biopharma
• Verification Date: January 2021