Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to describe the effects of repeated-dose methylnaltrexone in preventing loperamide-induced delay of whole-gut, oro-cecal and colon transit time and to measure pharmacokinetics of methylnaltrexone and naloxone-3-glucuronide after oral administration of methylnaltrexone and naloxone.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medicine Greifswald
• Treatments: Antidiarrheals; Loperamide; Methylnaltrexone; Naloxone; Naltrexone; Sulfasalazine

Criteria

Inclusion Criteria:

• age: 18 - 45 years

• sex: male and female

• ethnic origin: Caucasian

• minimal body weight: 62 kg

• body mass index:> 19 kg/m² and < 27 kg/m²

• good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which were judged by the clinical investigator not to differ in a clinical relevant way from the normal state

• written informed consent

Exclusion Criteria:

• hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication

• gastrointestinal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication

• drug or alcohol dependence

• positive drug or alcohol screening

• smokers of 10 or more cigarettes per day

• positive results in HIV, HBV and HCV screenings

• volunteers who are on a diet which could affect the pharmacokinetics of the drug

• heavy tea or coffee drinkers (more than 1L per day)

• lactation, pregnancy test positive or not performed or women of child-bearing age without safe contraception

• volunteers suspected or known not to follow instructions of the clinical investigators

• volunteers who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study

• volunteers liable to orthostatic dysregulation, fainting, or blackouts

• participation in a clinical trial during the last 3 months prior to the start of the study

• less than 14 days after last acute disease

• less than 3 months after last blood donation

• any medication within 4 weeks prior to the intended first administration of the study medication which might influence functions of the gastrointestinal tract (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists, proton pump inhibitors)

• any other medication within two weeks prior to the first administration of the study medication, but at least 10-time the half-life of the respective drug (except oral contraceptives)

• intake of grapefruit containing food or beverages within 14 days prior to administration of the study medication

• known allergic reactions to the active ingredients used or to constituents of the study medication