NCT02726438

Drug Penetration Into Bone After Repeated Oral Administration of Debio 1450 to Patients Undergoing Hip Replacement Surgery

A Phase 1, Open-Label Pharmacokinetic Study to Investigate Drug Penetration in the Bone After Repeated Oral Administration of Debio 1450 to Patients Undergoing Hip Replacement Surgery

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Debio 1450 is being developed for the treatment of staph (staphylococcal) infections. How fast and completely an antibiotic penetrates into bone is used to determine how effective it might be to treat infections related to bones or joints. Since bone has fewer blood vessels than other tissue (for example lung tissue or the skin), drugs have a harder time getting into them. It is important to find out how much of the antibiotic can get into the bone to help patients with bone infections.

Conditions

• Bone Diseases, Infectious

Interventions

Type	Name	Description
DRUG	Debio 1450	Debio 1450, 40 mg, powder for oral solution, for reconstitution in 5% dextrose in water.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-04-01
• Last updated: 2017-10-18

Locations

2 sites across 1 country: United States