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Loperamide / Red Grapefruit Juice

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00806299Loperamide Grapefruit Juice Interaction PK TrialPHASE1 COMPLETED 33 — — Nov 1, 2008Nov 1, 2008Oct 6, 20111 United States
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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 — 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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