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Loperamide/ Red Grapefruit Juice

Phase 1

Drug Interaction | Small molecule | Other |Johnson & Johnson|Last Updated: Oct 6, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

Loperamide/ Red Grapefruit Juice · 1 trial · 1 indication

Phase 1 1
NCT00806299Loperamide Grapefruit Juice Interaction PK TrialDrug Interaction
COMPLETED33 Analytics
PHASE1COMPLETED
Loperamide Grapefruit Juice Interaction PK Trial
Drug Interaction
NCT0080629933
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Study Endpoints

Primary Endpoints

Pharmacokinetic parameters
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 Endpoints

Pharmacodynamic Parameter: Urine for Analysis of Cortisol and 6-beta Hydroxycortisol
8 PM to about 6 AM prior to each dose administration, Day 1, Day 3 and Day 8
Pharmacodynamic Parameter: Pupillometry Assessments
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
pre-dose or post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDrug (including placebo)
2EXPERIMENTALDrug (including placebo)
3EXPERIMENTALDrug (including placebo)

Interventions

NameTypeDescription
Loperamide / Red Grapefruit JuiceDRUGFixed sequence of loperamide 4 mg with and without red grapefruit juice
Loperamide/ White Grapefruit JuiceDRUGFixed sequence of loperamide 4 mg with and without white grapefruit juice
Loperamide / Pink Grapefruit JuiceDRUGFixed sequence of loperamide 4 mg with and without pink grapefruit juice
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Eligibility Criteria

Age Range18 Years to 59 Years
SexALL
Healthy VolunteersYes
Study Sites1

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. * ...

Countries:United States
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Frequently asked questions about Loperamide/ Red Grapefruit Juice

What is Loperamide used for?

Loperamide is a small molecule drug being studied for use in drug interaction trials and in healthy participants. It is developed by Johnson & Johnson (JNJ). The drug is currently in Phase 1 clinical development, with studies focused on evaluating its effects and interactions in controlled settings.

Who makes Loperamide?

Loperamide is developed by Johnson & Johnson, a company traded under the ticker JNJ. The drug is currently in Phase 1 clinical development, with ongoing studies evaluating its effects in healthy participants and drug interaction scenarios.

What phase is Loperamide in?

Loperamide is in Phase 1 clinical development. It has completed two Phase 1 trials, one studying drug interaction and another evaluating its effects on electrocardiogram intervals in healthy participants. The drug is investigational and not yet approved for any indication.

What clinical trials is Loperamide in?

Loperamide has been studied in two completed Phase 1 trials. NCT00806299 examined grapefruit juice interaction, and NCT04225078 evaluated its effects on electrocardiogram intervals in healthy adults. Both trials were completed, with a combined enrollment of 99 participants.

Is Loperamide FDA approved?

Loperamide is not FDA approved for the indications being studied. It is an investigational drug currently in Phase 1 clinical development, with completed trials focusing on drug interactions and healthy participant safety. Approval status beyond these studies is not established.