Clinical trial NCT03408470: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intestinal Disorders
Bowel Diseases, Inflammatory
Keywords: Absolute Bioavailability
ADME
Healthy Normal Males
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2018-01-24
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Maximum observed concentration (Cmax) in Plasma
timeFrame: Up to 15 days
measure: Time to maximum observed concentration (tmax) in Plasma
timeFrame: Up to 15 days
measure: Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma
timeFrame: Up to 15 days
measure: Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma
timeFrame: Up to 15 days
measure: Apparent terminal elimination half-life (t1/2) in Plasma
timeFrame: Up to 15 days
measure: Apparent clearance (Cl/F) in Plasma
timeFrame: Up to 15 days
measure: Apparent volume of distribution (Vz/F) in Plasma
timeFrame: Up to 15 days
measure: Absolute bioavailability (%F) in Plasma
timeFrame: Up to 15 days
Secondary outcomes:
measure: Amount excreted in urine (Aeu) over the sampling interval in Urine
timeFrame: Up to 15 days
measure: Renal clearance (CLr) in Urine
timeFrame: Up to 15 days
measure: The percent excreted in urine (%Feu) in Urine
timeFrame: Up to 15 days
measure: Amount excreted in feces (Aef) over the sampling interval in Feces
timeFrame: Up to 15 days
measure: The percent excreted in feces (%Fef)
timeFrame: Up to 15 days
Other outcomes:
measure: Metabolites in Plasma
timeFrame: Up to 15 days
measure: Metabolites in Urine
timeFrame: Up to 15 days
measure: Metabolites in Feces
timeFrame: Up to 15 days
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: