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

Bowel Diseases, Inflammatory Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408470
• Other study ID #: 0152
• Status: Completed
• Phase: Phase 1
• Start date: January 31, 2018
• Est. completion date: February 21, 2018

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 21, 2018
• Est. primary completion date: February 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Diseases, Inflammatory
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Intestinal Disorders

Intervention

Drug:
• TD-1473 oral capsule
(Intervention description included in arm description)
• [14C]-TD-1473 IV bolus
(Intervention description included in arm description)
• [14C]-TD-1473 Oral Capsule
(Intervention description included in arm description)

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolites in Plasma	TD 1473 metabolite profiling will be performed in plasma containing sufficient amounts of radioactivity	Up to 15 days
Other	Metabolites in Urine	TD 1473 metabolite profiling will be performed in urine containing sufficient amounts of radioactivity	Up to 15 days
Other	Metabolites in Feces	TD-1473 metabolite profiling will be performed in feces containing sufficient amounts of radioactivity	Up to 15 days
Primary	Maximum observed concentration (Cmax) in Plasma		Up to 15 days
Primary	Time to maximum observed concentration (tmax) in Plasma		Up to 15 days
Primary	Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma		Up to 15 days
Primary	Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma		Up to 15 days
Primary	Apparent terminal elimination half-life (t1/2) in Plasma		Up to 15 days
Primary	Apparent clearance (Cl/F) in Plasma		Up to 15 days
Primary	Apparent volume of distribution (Vz/F) in Plasma		Up to 15 days
Primary	Absolute bioavailability (%F) in Plasma		Up to 15 days
Secondary	Amount excreted in urine (Aeu) over the sampling interval in Urine		Up to 15 days
Secondary	Renal clearance (CLr) in Urine		Up to 15 days
Secondary	The percent excreted in urine (%Feu) in Urine		Up to 15 days
Secondary	Amount excreted in feces (Aef) over the sampling interval in Feces		Up to 15 days
Secondary	The percent excreted in feces (%Fef)		Up to 15 days