Completed PHASE1 INTERVENTIONAL 4-arm NCT01367535

Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

A Phase I, Randomized, Open-Label, Active- and Placebo-Controlled Parallel Group Study of the Effect of Subcutaneous and Intravenous Methylnaltrexone on CYP450 2D6 Activity in Healthy Extensive Metabolizers of Dextromethorphan

Sponsor: Bausch Health Americas, Inc.

Conditions Healthy Adults

Interventions IV Methylnaltrexone (MNTX) Oral Paroxetine SC Methylnaltrexone (MNTX) SC Placebo

Updated 9 times since 2017 Last updated: Nov 26, 2019 Started: Mar 31, 2006 Primary completion: Aug 31, 2006 Completion: Aug 31, 2006

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

This PHASE1 trial investigates Healthy Adults and is currently completed. Bausch Health Americas, Inc. leads this study, which shows 9 recorded versions since 2006 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

9 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE1
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

▶ Show 4 earlier versions

Jun 2019 — Dec 2019 [monthly]

Completed PHASE1
Jun 2018 — Jun 2019 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Mar 2006

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