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

Theravance Biopharma

Status and phase: Completed; Phase 1

Conditions: Bowel Diseases, Inflammatory; Intestinal Disorders

Treatments: Drug: [14C]-TD-1473 IV bolus; Drug: TD-1473 oral capsule; Drug: [14C]-TD-1473 Oral Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03408470

0152

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

TD-1473 Oral Capsule & [14C]-TD-1473 IV bolus

Experimental group

Description:

Cohort 1 - One oral dose and IV bolus administered 1 hr after oral dose of TD-1473

Treatment:

Drug: [14C]-TD-1473 IV bolus

Drug: TD-1473 oral capsule

[14C]-TD-1473 Oral Capsule

Experimental group

Description:

Cohort 2 - One oral dose

Treatment:

Drug: [14C]-TD-1473 Oral Capsule