Loperamide Grapefruit Juice Interaction PK Trial

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A 10-day study to determine if grapefruit juice has any effect on how loperamide (Imodium) affects the body and how the body affects loperamide.

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

Details

• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Treatments: Antidiarrheals; Loperamide

Criteria

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 18 and 59 years, inclusive

• No clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, and clinical laboratory tests.

• Subjects will have a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

• Are normotensive with sitting blood pressure between the range of 90 - 140 mm Hg systolic and 50 - 90 mm Hg diastolic.

• Have a heart rate of 50-100 beats per minute (bpm).

• Have a negative urine drug screen at screening and at check-in to the research unit.

• If female of child-bearing potential, a negative pregnancy test at screening and at admission to the clinical research unit.

• Able to sign and date the informed consent document, indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

• Received a thorough explanation of the mandatory pharmacogenomic research component of the study and has signed the separate pharmacogenomic informed consent document.

• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

• Extensive restrictions on the type of food and drink allowed

• Medical history that precludes inclusion in the trial per protocol

• History of allergy and/or sensitivity to loperamide HCl

• History of alcohol consumption that precludes inclusion in the trial per protocol

• Positive screening test for HIV, Hepatitis B or Hepatitis C

• Treatment with an investigational drug within 30 days preceding the first dose of study medication

• Females who are pregnant, nursing, or unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in the protocol

• Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives prior to first dose

• Donated or lost blood or blood products within 3 months of first dose or intention to donate blood or blood products within one month after the last dose

• History of sensitivity to heparin or heparin-induced thrombocytopenia

• Unwillingness or inability to comply with the Lifestyle Guidelines listed in the protocol

• Relationship to persons involved directly with the conduct of the study