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NCT03408470 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Theravance Biopharma.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT03408470 is a Phase 1 study that has completed, run by Theravance Biopharma. The registered enrollment target is 20 participants.

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The verdict

NCT03408470, a Phase 1 study, has completed, sponsored by Theravance Biopharma.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study 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.

Interventions

  • DRUG TD-1473 oral capsule
  • DRUG [14C]-TD-1473 IV bolus
  • DRUG [14C]-TD-1473 Oral Capsule

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2018-01-31
Est. Completion 2018-02-21
Phase Phase 1

Sponsor

Theravance Biopharma

38 total trials

What the Registry Record Tells You About NCT03408470

The ClinicalTrials.gov registry entry for NCT03408470 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theravance Biopharma, which has 38 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which TD-1473 oral capsule is the first listed.

NCT03408470 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03408470 about?

NCT03408470 is a clinical study titled "TD-1473 Absorption, Distribution, Metabolism and Excretion (ADME) Study 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 ...

What is the current status of trial NCT03408470?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2018-01-31. Estimated completion is 2018-02-21.

What interventions are being tested in trial NCT03408470?

The interventions under investigation include: TD-1473 oral capsule (DRUG), [14C]-TD-1473 IV bolus (DRUG), [14C]-TD-1473 Oral Capsule (DRUG).

Who is sponsoring clinical trial NCT03408470?

This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.