Drug InteractionPhase 1NCT00806299
Loperamide Grapefruit Juice Interaction PK Trial
A Phase 1 study testing Loperamide / Red Grapefruit Juice, Loperamide/ White Grapefruit Juice and Loperamide / Pink Grapefruit Juice in people with Drug Interaction, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- Loperamide / Red Grapefruit Juice, Loperamide/ White Grapefruit Juice and Loperamide / Pink Grapefruit Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Single-dose, Fixed-Sequence Crossover Drug Interaction Study of Loperamide HCL With Grapefruit Juice
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.
Read the detailed description
An open-label, randomized, single-dose, fixed-sequence crossover drug interaction study of loperamide HCl with grapefruit juice. About 33 healthy subjects, about equal numbers of men and women, 18 through 59 years of age, will be enrolled into this 10 day trial. Subjects will be divided into three cohorts of about 11 subjects each. Each cohort will receive red, white or pink grapefruit juice. Subjects will take 4 mg of loperamide on Day 1. They will ingest 8 ounces of grapefruit juice and then 4 mg of loperamide on Day 3. They will ingest 8 ounces of grapefruit juice in the morning and in the evening on Days 5, 6 and 7. On Day 8, subjects will ingest 8 ounces of juice and then 4 mg of loperamide. Blood samples will be collected at at predose (0) and 0.5, 1, 1.5, 32, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36 and 46 hours after dosing on Day 1, Day 3 and Day 8. Pupillometry assessments will be performed at pre-dose (0) and 2, 4, 6, 8, and 12 hours after dosing on Day 1, Day 3 and Day 8. Subjects will collect their urine from about 8 PM to about 6 AM prior to dosing on Day 1, Day 3 and Day 8.
- Conditions
- Drug Interaction
- Being tested
- Loperamide / Red Grapefruit Juice, Loperamide/ White Grapefruit Juice, Loperamide / Pink Grapefruit Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loperamide / Red Grapefruit JuiceDrug
Also called Imodium
Fixed sequence of loperamide 4 mg with and without red grapefruit juice
Loperamide/ White Grapefruit JuiceDrug
Also called Imodium
Fixed sequence of loperamide 4 mg with and without white grapefruit juice
Loperamide / Pink Grapefruit JuiceDrug
Also called Imodium
Fixed sequence of loperamide 4 mg with and without pink grapefruit juice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drug (including placebo) Receives: Drug: Loperamide / Red Grapefruit Juice |
| 2 | Experimental | Drug (including placebo) Receives: Drug: Loperamide/ White Grapefruit Juice |
| 3 | Experimental | Drug (including placebo) Receives: Drug: Loperamide / Pink Grapefruit Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Measured: Blood samples will be collected before dosing (predose) and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36, and 46 hours following each of the three doses
Secondary outcomes (4)
Pharmacodynamic Parameter: Urine for Analysis of Cortisol and 6-beta Hydroxycortisol
Measured: 8 PM to about 6 AM prior to each dose administration, Day 1, Day 3 and Day 8
Pharmacodynamic Parameter: Pupillometry Assessments
Measured: predose (0) and at 2, 4, 6, 8, and 12 hours after dosing on Day 1, Day 3 and Day 8
Pharmacogenomic Evaluation - Genotype CYP3A4, CYP3A5, and ABCB1
Measured: pre-dose or post-dose
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product
Measured: throughout duration of the study (+ 30 days for spontaneously reported SAEs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dolly Parasrampuria, PhD, Study director, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806299
- Sponsor's protocol ID
- LOPDIR1007
- Status last verified
- Oct 2011
- First submitted
- 9 Dec 2008
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Single-dose, Fixed-Sequence Crossover Drug Interaction Study of Loperamide HCL With Grapefruit Juice
- ClinicalTrials.gov ID
- NCT00806299
- Acronym / sponsor ID
- LOPDIR1007
- Conditions
- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An open-label, randomized, single-dose, fixed-sequence crossover drug interaction study of loperamide HCl with grapefruit juice. About 33 healthy subjects, about equal numbers of men and women, 18 through 59 years of age, will be enrolled into this 10 day trial. Subjects will be divided into three cohorts of about 11 subjects each. Each cohort will receive red, white or pink grapefruit juice. Subjects will take 4 mg of loperamide on Day 1. They will ingest 8 ounces of grapefruit juice and then 4 mg of loperamide on Day 3. They will ingest 8 ounces of grapefruit juice in the morning and in the evening on Days 5, 6 and 7. On Day 8, subjects will ingest 8 ounces of juice and then 4 mg of loperamide. Blood samples will be collected at at predose (0) and 0.5, 1, 1.5, 32, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36 and 46 hours after dosing on Day 1, Day 3 and Day 8. Pupillometry assessments will be performed at pre-dose (0) and 2, 4, 6, 8, and 12 hours after dosing on Day 1, Day 3 and Day 8. Subjects will collect their urine from about 8 PM to about 6 AM prior to dosing on Day 1, Day 3 and Day 8.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Loperamide / Red Grapefruit JuiceDrug (including placebo) |
| 2 | Experimental | Drug: Loperamide/ White Grapefruit JuiceDrug (including placebo) |
| 3 | Experimental | Drug: Loperamide / Pink Grapefruit JuiceDrug (including placebo) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loperamide / Red Grapefruit JuiceAlso: ImodiumFixed sequence of loperamide 4 mg with and without red grapefruit juice | Drug | 1 |
| Loperamide/ White Grapefruit JuiceAlso: ImodiumFixed sequence of loperamide 4 mg with and without white grapefruit juice | Drug | 2 |
| Loperamide / Pink Grapefruit JuiceAlso: ImodiumFixed sequence of loperamide 4 mg with and without pink grapefruit juice | Drug | 3 |
Primary outcome
Pharmacokinetic parameters
Time frame: Blood samples will be collected before dosing (predose) and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36, and 46 hours following each of the three doses
4 secondary outcomes
Pharmacodynamic Parameter: Urine for Analysis of Cortisol and 6-beta Hydroxycortisol
Time frame: 8 PM to about 6 AM prior to each dose administration, Day 1, Day 3 and Day 8
Pharmacodynamic Parameter: Pupillometry Assessments
Time frame: predose (0) and at 2, 4, 6, 8, and 12 hours after dosing on Day 1, Day 3 and Day 8
Pharmacogenomic Evaluation - Genotype CYP3A4, CYP3A5, and ABCB1
Time frame: pre-dose or post-dose
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product
Time frame: throughout duration of the study (+ 30 days for spontaneously reported SAEs)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dolly Parasrampuria, PhD study director
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Loperamide / Red Grapefruit Juice, Loperamide/ White Grapefruit Juice and Loperamide / Pink Grapefruit Juice in people with Drug Interaction, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters (time frame: Blood samples will be collected before dosing (predose) and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36, and 46 hours following each of the three doses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2011.