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

Bone Diseases, Infectious Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726438
• Other study ID #: Debio 1450-108
• Secondary ID: 226488
• Status: Completed
• Phase: Phase 1
• First received: March 29, 2016
• Last updated: October 17, 2017
• Start date: April 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: Debiopharm International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Meets protocol-specified criteria for qualification and contraception

• Is willing and able to comply with restrictions related to food, drink and medications

• Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

• Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters

• Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

1. the safety or well-being of the participant or study staff;

2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);

3. the analysis of results

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Infectious
• Communicable Diseases
• Infection

Intervention

Drug:
• Debio 1450
Debio 1450, 40 mg, powder for oral solution, for reconstitution in 5% dextrose in water.

Locations

Country	Name	City	State
United States	Mercury St Medical Group, PLLC	Butte	Montana
United States	eStudySite	La Mesa	California

Sponsors (1)

Lead Sponsor	Collaborator
Debiopharm International SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone to plasma ratio for Debio 1452 (the Debio 1450 active moiety)	Bone/bone marrow/soft tissue/synovial fluid samples will be collected during surgery; time of resection will be used to calculate the elapsed time after last dosing.	at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
Secondary	Plasma ratios for Debio 1452	Categories: Bone marrow:plasma; soft tissue:plasma; synovial fluid:plasma	at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
Secondary	Area under the curve at steady state (AUCt) of Debio 1452		at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
Secondary	Maximum observed plasma concentration (Cmax) of Debio 1452		at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant
Secondary	Measured concentration at the end of a dosing interval at steady state (Ctrough) of Debio 1452		at pre-last dose (predose of the 3rd dose), at 0.5, 1, 2, 3, 5, 8, 12 hours post-last dose (Dose 3) and at the time of bone resection (surgery); only at the time of bone resection for the calibration participant