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NCT01367483
An Open-Label, Phase I, Single Dose Study of the Pharmacokinetics, Mass Balance and Disposition of Intravenously Administered 14C-Methylnaltrexone in Normal, Healthy Volunteers
Phase 1 trial testing IV methylnaltrexone (MNTX) in Healthy Male Volunteers in 6 participants. Completed in 1 June 2005.
1 June 2005
Quick facts
| Lead sponsor | Bausch Health Americas, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 1 June 2005 |
| Primary completion | 1 June 2005 |
| Estimated completion | 1 June 2005 |
| Sites | 1 location across United States |
Drugs / interventions tested
- IV methylnaltrexone (MNTX) — full drug profile →
Conditions studied
- Healthy Male Volunteers — all drugs for Healthy Male Volunteers →
Sponsor
Bausch Health Americas, Inc. — full company profile →
Who can join
Adults 18 to 45, male only, with Healthy Male Volunteers. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX
Time frame: 5.5 days
To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.
Sponsor's own description
This is an open-label, radiotracer study, to be conducted in healthy, normal, male volunteers. It will entail intravenous administration of a single dose of 14C-MNTX, collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be sampled as a measure of the extent of possible metabolic MNTX demethylation.
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:
- PubMed search for NCT01367483
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy Male Volunteers
Currently open trials in the same condition.
- NCT07479745 — Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 · Phase 1 · recruiting
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)
- Trial protocol + status: ClinicalTrials.gov NCT01367483 (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/NCT01367483.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing