Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Single Centre, Open-label, 5-Period, Cross Over, Randomized Study in Healthy Elderly Subjects to Evaluate the Relative Bioavailability of Hydrobromide Salt and Free Base Immediate Release Tablet Formulations of Danirixin in the Fed State, and to Evaluate the Effect of Food and Gastric Acid Secretion Suppression on Danirixin Pharmacokinetics Following Administration of Hydrobromide Salt Tablets
The current study will help to increase our understanding of the pharmacokinetics (PK) of
danirixin. The primary objective of the study is to estimate the relative bioavailability of
danirixin Hydrobromide (HBr) tablet, when compared to danirixin free base (FB). Safety and
tolerability information for oral administration of danrixin HBr tablets in elderly subjects
will also be obtained. Secondarily, this study will evaluate effect of food on PK of
danirixin HBr, effect of gastric acid suppression, and within-subject PK variability of
danirixin HBr. The outcome of this study will contribute to the selection of the most
appropriate formulation/dosing regimen for future studies.
This is an open-label, 5-period crossover study. Study will be conducted in 18 healthy
elderly subjects. Screening will occur within 42 days prior to Day 1 of period 1. The
Treatment Periods will be separated by a washout period of a minimum 5 days. Follow-up will
be done within 3 to 10 days post last dose.
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