Prohibited and Concomitant Medication Sample Clauses

Prohibited and Concomitant Medication. Any prescription medication or over the counter medication taken from 30 days prior to the time of consent to the End of Study/Early Termination Visit will be recorded in the subject’s medical record (source document) and Case Report Form (CRF). Once a subject is considered eligible, prior to Day 1, a concomitant medication form will be completed by the site and reviewed by the sponsor for approval. Use of the following medication prior to and during the study is prohibited: • Any drugs or substances known to be strong inhibitors or inducers of CYP3A4/5 and drugs whose major elimination pathway is via the BSEP or OAT3 transporters, and drugs that are major substrates of the hepatic uptake transporters OATP1B1 and OATP1B3 received within 30 days prior to the first dose of study drug. (NOTE: Please refer to Appendix A and if there are questions, please contact the sponsor); • Systemic immunosuppressants, with the exception of short-term treatment for asthma, received within 6 months prior to the first dose of study drug and during the study; • Any investigational product or investigational device received within 30 days prior to the first dose of study drug and during the study. For questions regarding the use of medications, the investigator should contact the sponsor for further discussion. In case of an acute medical emergency, discussion with the Sponsor is excluded and the subject should be treated according to the judgement of the PI. Consumption of foods and beverages containing the following substances will be prohibited as indicated: • Xanthines/caffeine: 24 hours prior to dosing and throughout the period of PK sample collection; • Alcohol: 48 hours prior to dosing and throughout the period of PK sample collection; • Grapefruit/Seville orange: 14 days prior to dosing and throughout the period of PK sample collection.
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