Example Analysis of a Food Effect Phase I Clinical Trial

EXAMPLE ANALYSIS OF A FOOD EFFECT PHASE I CLINICAL TRIAL 

To assess whether food impacted the pharmacokinetics of a new drug, such a study was conducted in 12 healthy, male subjects. Plasma samples were collected and analyzed for drug concentrations. AUC(0—oo) was calculated using the linear trapezoidal rule and Cn3. was determined from direct observation of the data. 

AUC(0—oo) and Cmax are presented in Table 6.5. Two subjects did not return to the clinic and did not complete the study. Hence, these subjects had only data from Period 1. Natural-log transformed AUC(0—oo) and Cmax were used as the dependent variables. The analysis of variance consisted of sequence, treatment, and period as fixed effects. Subjects nested within sequence were treated as a random effect using a random intercept model. The model was fit using REML. Table 6.6 presents the results. The 90% Cl for the ratio of treatment means for both AUC(0—oo) and Cmax were entirely contained within the interval 80-125%. Hence, it was concluded that food had no effect on the pharmacokinetics of the drug. 

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