Bowel Diseases, Inflammatory, Intestinal Disorders
Conditions
Keywords
Absolute Bioavailability, ADME, Healthy Normal Males
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.
Interventions
DRUGTD-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)
Sponsors
Theravance Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute bioavailability (%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 |
| Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma | Up to 15 days |
| Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma | Up to 15 days |
| Apparent terminal elimination half-life (t1/2) in Plasma | Up to 15 days |
| Apparent clearance (Cl/F) in Plasma | Up to 15 days |
| Apparent volume of distribution (Vz/F) in Plasma | Up to 15 days |
Secondary
| Measure | Time frame |
|---|---|
| The percent excreted in feces (%Fef) | 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Metabolites in Urine | Up to 15 days | TD 1473 metabolite profiling will be performed in urine containing sufficient amounts of radioactivity |
| Metabolites in Feces | Up to 15 days | TD-1473 metabolite profiling will be performed in feces containing sufficient amounts of radioactivity |
| Metabolites in Plasma | Up to 15 days | TD 1473 metabolite profiling will be performed in plasma containing sufficient amounts of radioactivity |
Countries
United States
Outcome results
None listed