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

NCT ID: NCT03408470

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2018-02-21

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.

Conditions

Intestinal Disorders; Bowel Diseases, Inflammatory

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

TD-1473 oral capsule

Intervention Type: DRUG

(Intervention description included in arm description)

[14C]-TD-1473 IV bolus

Intervention Type: DRUG

(Intervention description included in arm description)

[14C]-TD-1473 Oral Capsule

Cohort 2 - One oral dose

Group Type: EXPERIMENTAL

[14C]-TD-1473 Oral Capsule

Intervention Type: DRUG

(Intervention description included in arm description)

Interventions

TD-1473 oral capsule

(Intervention description included in arm description)

Intervention Type: DRUG

[14C]-TD-1473 IV bolus

(Intervention description included in arm description)

Intervention Type: DRUG

[14C]-TD-1473 Oral Capsule

(Intervention description included in arm description)

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Theravance Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Theravance Biopharma

Locations

Celerion

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

0152

Identifier Type: -

Identifier Source: org_study_id