A Study of the Effect of Methylnaltrexone on Movement Through the Digestive Tract in Healthy Volunteers


About this study

The purpose of this study is to evaluate the effects of methylnaltrexone  on movement of solids through the digestive tract in healthy human subjects.


Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Males and non-pregnant, non-breastfeeding females
  • Age 18-65 years
  • No functional GI disorders on the short Bowel Disease Questionnaire (BDQ)
  • A BMI greater than 22.0

Exclusion Criteria

  • Structural or metabolic diseases/conditions that affect the gastrointestinal system or functional gastrointestinal disorders
    • The short version of the Bowel Disease Questionnaire (BDQ) will be exclude functional GI disorders
    • More than three positive responses will exclude participation
  • Any medication that alters GI transit and unable to withdraw from them 48 hours prior to study entry, including but not limited to
    • Laxatives
    • Magnesium or aluminum-containing antacids
    • Prokinetics
    • Erythromycin
    • Narcotics
    • Anticholinergics
    • Tricyclic antidepressants
    • SSRI and newer antidepressants
    • Analgesic drugs including opiates, NSAID, and COX 2 inhibitors 
      • Tylenol is permitted
    • GABAergic agents and benzodiazepines
      • Concomitant medications will be reviewed on a case by case basis by the study physicians
  • Considered by the investigator to be alcoholics not in remission or known substance abusers
    • Alcohol must be avoided from seven days prior to beginning the study medication until the completion of the study
  • Participated in another clinical study within the past 30 days
  • Clinical evidence (including physical exam and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D.

Closed for enrollment

More information


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