Obeticholic Acid + Omeprazole = Unknown or no reaction

Effect on Concentration

Obeticholic Acid
No change
Applies within class?
No
Omeprazole
Increase
Applies within class?
No

Pharmacologic Effects

Obeticholic Acid
Effect
N/A
Applies within class?
No
Omeprazole
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 20-Jul-2018

Summary

Sources

Obeticholic Acid versus Omeprazole ^

Study Design

In a fixed-sequence and 2-period study in n=19-24 healthy subjects were given a single oral dose of 20mg of omeprazole on day 1 and day 18. Obeticholic acid (OCA) 10mg or 25 mg daily alone was given for 17 days prior to the administration of the second omeprazole dose.

Study Results

Following multiple doses of OCA 10mg QD, AUC and Cmax of omeprazole increased by 32% and 33% respectively. Following multiple doses of OCA 25mg QD, AUC and Cmax of omeprazole increased by 19% and 17% respectively.

Study Conclusions

Per the investigators, the increase in systemic exposure of omeprazole does not have clinical effect as omeprazole can be dosed up to 60mg QD.

References

Edwards JE, Eliot L, Parkinson A, Karan S, MacConell L. Assessment of pharmacokinetic interactions between obeticholic acid and caffeine, midazolam, warfarin, dextromethorphan, omeprazole, rosuvastatin, and digoxin in phase 1 studies in healthy subjects. Advances In Therapy. 2017; 9: 2120-2138.