Obeticholic Acid + Digoxin = Unknown or no reaction

Effect on Concentration

Obeticholic Acid
No change
Applies within class?
No
Digoxin
No change
Applies within class?
No

Pharmacologic Effects

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

Interaction History

N/A

Last Updated 20-Jul-2018

Summary

Sources

Obeticholic Acid versus Digoxin ^

Study Design

In a fixed-sequence and 2-period study in n=24 healthy subjects were given a single oral dose of 0.25mg of digoxin on day 1 and day 19. Obeticholic acid (OCA) 10mg or 25 mg daily alone was given for 13 days prior to the administration of the second digoxin dose.

Study Results

Following multiple doses of OCA 10mg QD, AUC increased by 1.2% while Cmax decreased by 3.3%, renal clearance of digoxin remained the same. Following multiple doses of OCA 25mg QD, AUC and Cmax of digoxin increased by 7.3% and 23.6% respectively, renal clearance of digoxin is reduced by 2.1%.

Study Conclusions

Per the investigators, no dose adjustment is needed when 10mg OCA is co-administered with digoxin.

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.