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



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:19 - 55
Updated:2/7/2018
Start Date:January 31, 2018
End Date:April 30, 2018
Contact:Kit Chiu, MS, PhD
Email:KChiu@theravance.com
Phone:650-808-6000

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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

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.


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
We found this trial at
1
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Lincoln, Nebraska 68502
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Lincoln, NE
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