Status:
COMPLETED
TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects
Lead Sponsor:
Theravance Biopharma
Conditions:
Intestinal Disorders
Bowel Diseases, Inflammatory
Eligibility:
MALE
19-55 years
Phase:
PHASE1
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 receiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03408470
Start Date
January 31 2018
End Date
February 21 2018
Last Update
January 14 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Celerion
Lincoln, Nebraska, United States, 68502