NCT04268394

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

A Phase 1, Open-label Study in Healthy Adult Subjects to Evaluate Effects of Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-99677 and the Effects of CC-99677 on the Pharmacokinetics of Digoxin, Metformin, Methotrexate, Midazolam, Rosuvastatin, and Sulfasalazine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Detailed description

This study will allow investigation of potential drug-drug interaction mediated through cytochrome P450 enzymes and drug transporter proteins. During each part, blood samples will be collected at prespecified times for pharmacokinetic assessments. Subject safety will be monitored throughout the study. There will be approximately 16 subjects enrolled into each part.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	CC-99677	CC-99677
DRUG	Methotrexate	Methotrexate
DRUG	Sulfasalazine	Sulfasalazine
DRUG	Itraconazole	Itraconazole
DRUG	Rifampin	Rifampin
DRUG	Midazolam	Midazolam
DRUG	Digoxin	Digoxin
DRUG	Metformin	Metformin
DRUG	Rosuvastatin	Rosuvastatin

Timeline

• Start date: 2020-03-13
• Primary completion: 2021-06-02
• Completion: 2021-06-02
• First posted: 2020-02-13
• Last updated: 2021-08-18

Locations

1 site across 1 country: United Kingdom