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Completed

NCT Number: NCT02726438

Drug Penetration Into 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.

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Key information

Conditions

Bone Diseases, Infectious Bone Diseases Infections Musculoskeletal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

eStudySite, La Mesa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • the safety or well-being of the participant or study staff;
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
  • the analysis of results

Treatment and study plan

Debio 1450

Drug

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

Primary outcomes

  1. Bone to plasma ratio for Debio 1452 (the Debio 1450 active moiety)

    Time frame: 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

    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.

Secondary outcomes

  1. Plasma ratios for Debio 1452

    Time frame: 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

    Categories: Bone marrow:plasma; soft tissue:plasma; synovial fluid:plasma

  2. Area under the curve at steady state (AUCτ) of Debio 1452

    Time frame: 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

  3. Maximum observed plasma concentration (Cmax) of Debio 1452

    Time frame: 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

  4. Measured concentration at the end of a dosing interval at steady state (Ctrough) of Debio 1452

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 1, 2016
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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