Completed PHASE1 INTERVENTIONAL 1-arm NCT01367522

Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function

A Phase 1, Open-Label, Study to Evaluate Single Dose Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Volunteers With Impaired Hepatic Function

Sponsor: Bausch Health Americas, Inc.

Conditions Liver Dysfunction

Interventions SC Methylnaltrexone (MNTX)

Updated 8 times since 2017 Last updated: Nov 26, 2019 Started: Mar 31, 2004 Primary completion: Jul 31, 2004 Completion: Jul 31, 2004

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01367522, this PHASE1 trial focuses on Liver Dysfunction and remains completed. Sponsored by Bausch Health Americas, Inc., it has been updated 8 times since 2004, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Dec 2019 — Jan 2021 [monthly]

Completed PHASE1
Jun 2019 — Dec 2019 [monthly]

Completed PHASE1

▶ Show 3 earlier versions

Jun 2018 — Jun 2019 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Mar 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bausch Health Americas, Inc.

Data source: Bausch Health Americas, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Tarrytown, United States