Gain Early Access to Quality DDI Data
Knowledge of potential drug-drug interactions (DDIs) is important in risk reduction, continued optimal delivery of patient care, and maximization of commercial success of your molecule’s journey.
Altasciences is well-versed in designing, conducting, and reporting on stand-alone studies for each inhibitor or substrate, as well as cocktail studies to assess interactions of multiple CYP enzymes or transporters in a single study.
Clinical Operation Highlights
- Expertise and Efficiency: Our sizeable patient database includes poor and extensive metabolizers of various CYP enzymes, complemented by historical genotyping data for rapid recruitment. We typically achieve First Subject First Visit (FSFV) in approximately 10 weeks from the final protocol.
- Skilled Clinical Operations: Our clinical operations staff are experts at managing participant safety, and are accustomed to managing the fast pace of DDI studies, expertly handling 60+ patients simultaneously.
- Comprehensive Support: Our Data Analysis, Medical Writing, and Scientific Affairs teams provide full-service, customized insights, including study design, rapid database development, biostatistics, and PK analysis, as well as executive summary analysis and detailed clinical study reports.
- Guidance on Follow-Up Studies: Should significant interactions be seen with the strong inducers or inhibitors, we will work with you to design follow-up studies with weak inhibitors and offer guidance for dosing adjustments.
You may also be interested in the following resources:
- Fact Sheet: Drug-Drug Interaction Clinical Trials
- Case Study: Drug-Drug Interaction Study on a Novel Cardiovascular Medication