NCT01366365 is a Phase 1 clinical trial of methylnaltrexone in Healthy Adults, sponsored by Bausch Health Americas, Inc..

Who is sponsoring NCT01366365?

NCT01366365 is sponsored by Bausch Health Americas, Inc..

What drugs are being tested in NCT01366365?

Interventions in NCT01366365: methylnaltrexone, placebo.

What condition does NCT01366365 study?

NCT01366365 studies Healthy Adults.

Is NCT01366365 still recruiting?

NCT01366365 is currently completed. Last updated 26 November 2019.

Last reviewed 2019-11-26 · How we verify

NCT01366365

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

A Phase 1 Randomized, Double-Blind, Placebo Controlled Parallel Group Study of the Pharmacokinetics, Safety and Tolerability of Methylnaltrexone Bromide Administered as Single and Multiple Intravenous Doses to Healthy Adults and Elderly Male and Female Subjects

Completed Phase 1 Last updated 26 November 2019

What this trial tests

Phase 1 trial testing methylnaltrexone in Healthy Adults in 28 participants. Completed in 1 November 2006.

Timeline

1 October 2006

Primary endpoint
1 November 2006

1 November 2006

Quick facts

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	28
Start date	1 October 2006
Primary completion	1 November 2006
Estimated completion	1 November 2006
Sites	1 location across United States

Drugs / interventions tested

methylnaltrexone (METHYLNALTREXONE) — full drug profile →
placebo

Conditions studied

Healthy Adults — all drugs for Healthy Adults →

Sponsor

Bausch Health Americas, Inc. — full company profile →

Who can join

18 and older, any sex, with Healthy Adults. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Clearance of MNTX
Time frame: 7 days
Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

Sponsor's own description

This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.

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:

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Other Bausch Health Americas, Inc. trials

Trials by the same sponsor.

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NCT05098028 — Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease · Phase 2 · completed
NCT05027282 — Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatm · NA · completed
NCT05132231 — Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Wor · active not recruiting

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 NCT01366365 (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 Bausch Health Americas, Inc.
Last refreshed: 26 November 2019

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/NCT01366365.

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