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

Primary Purpose

Intestinal Disorders, Bowel Diseases, Inflammatory

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

TD-1473 oral capsule

[14C]-TD-1473 IV bolus

[14C]-TD-1473 Oral Capsule

About this trial

This is an interventional basic science trial for Intestinal Disorders focused on measuring Absolute Bioavailability, ADME, Healthy Normal Males

Eligibility Criteria

19 Years - 55 Years (Adult)MaleAccepts 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

Sites / Locations

Celerion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

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

[14C]-TD-1473 Oral Capsule

Arm Description

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

Cohort 2 - One oral dose

Outcomes

Primary Outcome Measures

Maximum observed concentration (Cmax) in Plasma

Time to maximum observed concentration (tmax) in Plasma

Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma

Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma

Apparent terminal elimination half-life (t1/2) in Plasma

Apparent clearance (Cl/F) in Plasma

Apparent volume of distribution (Vz/F) in Plasma

Absolute bioavailability (%F) in Plasma

Secondary Outcome Measures

Amount excreted in urine (Aeu) over the sampling interval in Urine

Renal clearance (CLr) in Urine

The percent excreted in urine (%Feu) in Urine

Amount excreted in feces (Aef) over the sampling interval in Feces

The percent excreted in feces (%Fef)

Full Information

NCT ID

NCT03408470

First Posted

January 12, 2018

Last Updated

January 12, 2021

Sponsor

Theravance Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT03408470

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

January 31, 2018 (Actual)

Primary Completion Date

February 21, 2018 (Actual)

Study Completion Date

February 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theravance Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intestinal Disorders, Bowel Diseases, Inflammatory

Keywords

Absolute Bioavailability, ADME, Healthy Normal Males

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

[14C]-TD-1473 Oral Capsule

Arm Type

Experimental

Arm Description

Cohort 2 - One oral dose

Intervention Type

Drug

Intervention Name(s)

TD-1473 oral capsule

Intervention Description

(Intervention description included in arm description)

Intervention Type

Drug

Intervention Name(s)

[14C]-TD-1473 IV bolus

Intervention Description

(Intervention description included in arm description)

Intervention Type

Drug

Intervention Name(s)

[14C]-TD-1473 Oral Capsule

Intervention Description

(Intervention description included in arm description)

Primary Outcome Measure Information:

Title

Maximum observed concentration (Cmax) in Plasma

Time Frame

Up to 15 days

Title

Time to maximum observed concentration (tmax) in Plasma

Time Frame

Up to 15 days

Title

Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma

Time Frame

Up to 15 days

Title

Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma

Time Frame

Up to 15 days

Title

Apparent terminal elimination half-life (t1/2) in Plasma

Time Frame

Up to 15 days

Title

Apparent clearance (Cl/F) in Plasma

Time Frame

Up to 15 days

Title

Apparent volume of distribution (Vz/F) in Plasma

Time Frame

Up to 15 days

Title

Absolute bioavailability (%F) in Plasma

Time Frame

Up to 15 days

Secondary Outcome Measure Information:

Title

Amount excreted in urine (Aeu) over the sampling interval in Urine

Time Frame

Up to 15 days

Title

Renal clearance (CLr) in Urine

Time Frame

Up to 15 days

Title

The percent excreted in urine (%Feu) in Urine

Time Frame

Up to 15 days

Title

Amount excreted in feces (Aef) over the sampling interval in Feces

Time Frame

Up to 15 days

Title

The percent excreted in feces (%Fef)

Time Frame

Up to 15 days

Other Pre-specified Outcome Measures:

Title

Metabolites in Plasma

Description

TD 1473 metabolite profiling will be performed in plasma containing sufficient amounts of radioactivity

Time Frame

Up to 15 days

Title

Metabolites in Urine

Description

TD 1473 metabolite profiling will be performed in urine containing sufficient amounts of radioactivity

Time Frame

Up to 15 days

Title

Metabolites in Feces

Description

TD-1473 metabolite profiling will be performed in feces containing sufficient amounts of radioactivity

Time Frame

Up to 15 days

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Males only

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Theravance Biopharma

Official's Role

Study Director

Facility Information:

Facility Name

Celerion

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68502

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Learn more about this trial

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

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