A Phase 1, Open-label, Randomized, Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Subjects
Abstract
The main purpose of study is to evaluate the effect of multiple-dose administration of lansoprazole (and optional: time-separated single dose administration of ranitidine) on the pharmacokinetics (PK) of JNJ-63549109 after a single dose of lumicitabine in healthy adult participants, under fasted (and optional: fed) conditions.
Conditions: Healthy.
Primary outcome: Observed Plasma Concentration at 12 Hours Post dose (C12h) of JNJ-63549109 (Metabolite of JNJ- 64041575); Observed Plasma Concentration at 24 Hours Post dose (C24h) of JNJ-63549109 (Metabolite of JNJ- 64041575); Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of JNJ- 64041575); Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-63549109 (Metabolite of JNJ-64041575); Area Under Plasma Concentration Time Curve From Time Zero to the Last Quantifiable (AUC [0-last]) of JNJ-63549109 (Metabolite of JNJ-64041575); Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63549109 (Metabolite of JNJ-64041575); Elimination Half-Life (T1/2) of JNJ-63549109 (Metabolite of JNJ-64041575); Elimination Rate Constant (Lambda[z]) of JNJ-63549109 (Metabolite of JNJ-64041575).
Enrollment: 18 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 18 participants or records.
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