Who is sponsoring NCT04200573?

NCT04200573 is sponsored by Theravance Biopharma.

What drugs are being tested in NCT04200573?

Interventions in NCT04200573: Ampreloxetine.

What condition does NCT04200573 study?

NCT04200573 studies Symptomatic Neurogenic Orthostatic Hypertension, nOH.

Is NCT04200573 still recruiting?

NCT04200573 is currently completed. Last updated 8 September 2021.

Last reviewed 2021-09-08 · How we verify

NCT04200573

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of TD-9855

Completed Phase 1 Last updated 8 September 2021

What this trial tests

Phase 1 trial testing Ampreloxetine in Symptomatic Neurogenic Orthostatic Hypertension in 31 participants. Completed in 19 August 2021.

Timeline

13 January 2020

Primary endpoint
19 August 2021

19 August 2021

Quick facts

Lead sponsor	Theravance Biopharma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	13 January 2020
Primary completion	19 August 2021
Estimated completion	19 August 2021
Sites	2 locations across United States

Drugs / interventions tested

Ampreloxetine — full drug profile →

Conditions studied

Symptomatic Neurogenic Orthostatic Hypertension — all drugs for Symptomatic Neurogenic Orthostatic Hypertension →
nOH — all drugs for nOH →

Sponsor

Theravance Biopharma — full company profile →

Who can join

Adults 18 to 80, any sex, with Symptomatic Neurogenic Orthostatic Hypertension or nOH. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An open-label study to characterize the effects of mild, moderate, and severe Hepatic Impairment (HI) on the pharmacokinetics (PK) of ampreloxetine following a single oral dose in comparison with healthy volunteers with normal hepatic function.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Theravance Biopharma trials

Trials by the same sponsor.

NCT05165485 — Phase 4 COPD and Suboptimal Inspiratory Flow Rate · Phase 4 · completed
NCT05091723 — TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation · Phase 1 · completed
NCT04681079 — Comparison of Viral Particle Dispersion Following Administration of an MDI or Nebulizer in Subjects With COVID-19 · completed
NCT04688632 — Thorough QT Study to Evaluate Ampreloxetine in Healthy Subjects · Phase 1 · completed
NCT04587713 — Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04200573 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Theravance Biopharma
Last refreshed: 8 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04200573.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing