Obeticholic Acid + Caffeine = Unknown or no reaction

Effect on Concentration

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

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 20-Jul-2018

Summary

Sources

Obeticholic Acid versus Caffeine ^

Study Design

In a fixed-sequence and 2-period study in n=21-24 healthy subjects were given a single oral dose of 200mg of caffeine on day 1 and day 19. Obeticholic acid (OCA) 10mg or 25 mg daily alone was given for 14 days prior to the administration of the second caffeine dose.

Study Results

Following multiple doses of OCA 10mg QD, AUC and Cmax of caffeine increased by 42% and 6% respectively. Following multiple doses of OCA 25mg QD, AUC and Cmax of caffeine increased by 65% and 10% respectively.

Study Conclusions

Per the investigators, therapeutic monitoring should be implemented when OCA is co-administered with a CYP1A2 sensitive substrate which has a narrow therapeutic index.

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.