TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Bowel Diseases, InflammatoryIntestinal Disorders
- Interventions
- Drug: TD-1473 oral capsuleDrug: [14C]-TD-1473 Oral CapsuleDrug: [14C]-TD-1473 IV bolus
- Registration Number
- NCT03408470
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus TD-1473 oral capsule Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473 TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus [14C]-TD-1473 IV bolus Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473 [14C]-TD-1473 Oral Capsule [14C]-TD-1473 Oral Capsule Cohort 2 - One oral dose
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma Up to 15 days Apparent terminal elimination half-life (t1/2) in Plasma Up to 15 days Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma Up to 15 days Apparent volume of distribution (Vz/F) in Plasma Up to 15 days Maximum observed concentration (Cmax) in Plasma Up to 15 days Time to maximum observed concentration (tmax) in Plasma Up to 15 days Apparent clearance (Cl/F) in Plasma Up to 15 days Absolute bioavailability (%F) in Plasma Up to 15 days
- Secondary Outcome Measures
Name Time Method Amount excreted in feces (Aef) over the sampling interval in Feces Up to 15 days Amount excreted in urine (Aeu) over the sampling interval in Urine Up to 15 days Renal clearance (CLr) in Urine Up to 15 days The percent excreted in urine (%Feu) in Urine Up to 15 days The percent excreted in feces (%Fef) Up to 15 days
Trial Locations
- Locations (1)
Celerion
🇺🇸Lincoln, Nebraska, United States