drugset / Trial / NCT04268394

A Study to Evaluate Potential Cytochrome P450 and Transporter Protein Interactions With CC-99677

NCT04268394

Phase 1 Completed 48 enrolled Celgene Corporation
RandomizedParallel-groupOpen-labelTreatment

Summary

It is a phase 1, open-label, single-center, three-part study to assess the safety, tolerability, and pharmacokinetics of multiple doses of CC-99677 administered alone or in combination with either methotrexate and sulfasalazine; itraconazole, rifampin, midazolam, or a cocktail of digoxin, metformin, and rosuvastatin in healthy subjects

Timeline

Start
2020-03-13
Primary completion
2021-06-02
Completion
2021-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Digoxin Other / unclassified 0.25 mg
Subject GAMCEMETINIB Small molecule
Subject Itraconazole Small molecule 200 mg
Subject Metformin Small molecule 500 mg
Subject Methotrexate Small molecule 7.5 mg
Subject Midazolam Small molecule 2 mg
Subject Rifampin Small molecule 600 mg
Subject Rosuvastatin Small molecule 10 mg
Subject Sulfasalazine Small molecule 1000 mg

Indications

No indication recorded.