TD-4208 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects

NCT02772159 | Completed Phase 1

• 1 other identifier: 0130
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the absorption, distribution, metabolism and excretion of an investigational medication used to treat chronic obstructive pulmonary disease (COPD). The study drug will be tested in 6 healthy normal males. Dosing will include a single dose of study drug administered via an IV Infusion and an Oral Dose. There will be a 28 day washout period between each of the 2 dosing routes.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; ADME; Healthy Normal Males; Phase 1

Outcome Measures

Primary Outcomes (2)

• [14C] total radioactivity in urine and reported as the recovery in urine as a percentage of the administered dose

  up to 336 hours

• [14C] total radioactivity in feces and reported as the recovery in feces as a percentage of the administered dose

  up to 336 hours

Secondary Outcomes (4)

• Whole blood concentrations of total radioactivity

  up to 336 hours

• Plasma concentrations of total radioactivity

  up to 336 hours

• Plasma concentrations of TD-4208

  up to 336 hours

• Plasma concentrations of THRX-195518

  up to 336 hours

Study Arms (1)

Study Population

EXPERIMENTAL

One dose each of treatments A: \[14C\] TD-4208 20 μg IV administered in a fasted state over 30 minutes. B: \[14C\] TD-4208 200 μg oral solution administered in a fasted state.

Drug: TD-4208

Interventions

TD-4208 DRUG

One dose each of treatments A: \[14C\] TD-4208 20 μg IV administered in a fasted state over 30 minutes. B: \[14C\] TD-4208 200 μg oral solution administered in a fasted state.

Also known as: revefenacin

Study Population

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject has a body mass index 19 to 32 kg/m2, inclusive, and weigh at least 55 kg.
• Subject has normal blood pressure (BP) and heart rate (HR), measured after resting seated or supine for approximately 5 minutes. Normal BP is defined as 90 to 140 mm Hg systolic and 50 to 90 mm Hg diastolic. Normal HR is defined as 40 to 99 beats per minute.
• Subject is negative for hepatitis B, hepatitis C, and HIV antibodies.
• Subject has no clinically relevant abnormalities as determined by the investigator in the results of Screening or Day -1 laboratory evaluations.

You may not qualify if:

• 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 participated in another clinical trial of an investigational drug (or medical device) within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening, or are currently participating in another trial of an investigational drug (or medical device).
• Subject has a known hypersensitivity towards medications similar to TD-4208 or excipients contained in TD-4208.
• Subject has previously participated in a trial for TD-4208.
• 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 (radiological examination including CT scan excluding dental radiography) or internal radiation (diagnostic nuclear medicine procedure) or have participated in a radiolabeled study in the last 12 months.
• Subject has had exposure to external and/or internal radiotherapy with open (i.e., nuclear medicine) and sealed sources (i.e., brachytherapy) within the last 12 months.
• Subject, who, for any reason, is deemed by the investigator to be inappropriate for this study or have any condition which would confound or interfere with the evaluation of the safety, tolerability, PK of the investigational drug or prevent compliance with the study protocol.

Sponsors & Collaborators

• Mylan Inc.: lead
• Theravance Biopharma: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

revefenacin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Monitor

  Theravance Biopharma, US, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: May 13, 2016
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)