Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01367561
Other study ID # MNTX 206
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2002
Est. completion date May 2003

Study information

Verified date April 2023
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date May 2003
Est. primary completion date May 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Healthy males, 18 to 65 yrs with normal urinary function 2. Body weight less than 150 kg and Body Mass Index between 20-32. Exclusion Criteria: 1. Females 2. History of drug or alcohol abuse 3. History of significant chronic illness (cardiovascular, gastrointestinal, pulmonary, neurologic, endocrine, renal, hepatic, etc.) 4. Subjects who received opioids for one week or longer in the last 2 months.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Naloxone

IV Methylnaltrexone (MNTX)

Placebo


Locations

Country Name City State
United States Progenics Pharmaceuticals, Inc. Tarrytown New York

Sponsors (1)

Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal force of detrusor contraction (Pdet) after administration of MNTX To investigate the potential benefit of methylnaltrexone in preventing or treating opioid-induced urinary retention. 14 days
See also
  Status Clinical Trial Phase
Recruiting NCT04234594 - Comparing the Pharmacokinetic and Safety of QL1203 and Vectibix® in Healthy Males. Phase 1
Completed NCT00777543 - Increasing Ferulic Acid Bioavailability in Bran N/A
Recruiting NCT04756635 - Effects of Short- Term Intermittent Fasting Aerobic and Anaerobic Capacity N/A
Completed NCT02156661 - Oxytocin and Emotion Processing Phase 1
Completed NCT01848665 - The Influence of Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Passive Heat Stress Phase 4
Completed NCT05294198 - Beetroot Extract and Its Influence on Cardiovascular and Autonomic Recovery From the Effort in Healthy Males N/A
Completed NCT00839319 - HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone Phase 1/Phase 2
Completed NCT00842751 - Oral T7 Oral Testosterone in Man Phase 2
Completed NCT01847053 - Bioavailability Study of Cinnamon in Healthy Subjects Phase 1/Phase 2
Completed NCT01215292 - ITT4 Intratesticular Hormonal Milieu in Man (ITT4) Phase 1/Phase 2
Completed NCT00782392 - Bioavailability and Dosing of a Monosaccharide Supplement in Adults N/A
Completed NCT03714685 - Evaluation of the PK Profile of Firibastat Following Administration of Firibastat Prototype Tablet Formulations Phase 1
Completed NCT05277597 - Effect of a 4-week Post-exercise Sauna Bathing on Targeted Gut Microbiota N/A
Completed NCT01032616 - Uptake and Utilization of Amino Acids by Splanchnic Bed Phase 1
Completed NCT01830335 - Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Environmental Stress Phase 4
Completed NCT00902512 - Study Of Bioavailability Of Two Sildenafil 100mg Oral Tablet Formulations Phase 4
Completed NCT00475371 - A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males Phase 1
Completed NCT01870102 - Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR and Pelubiprofen SR (as a Pelubiprofen 45 mg) Tablet in Healthy Subjects Phase 1