Drug Penetration Into Bone After Repeated Oral Administration of Debio 1450 to Patients Undergoing Hip Replacement Surgery
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/20/2017 |
| Start Date: | April 2016 |
| End Date: | June 2017 |
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
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.
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.
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
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