Bacterial Infections
Conditions
Keywords
Antibiotic, Antibiotic Resistant Bacterial Infection
Brief summary
Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in NCT02214355). The registrations have been revised so all parts of this single trial (Parts A-C) are now included in this single registration (NCT02214433). The primary purpose of each part is provided below: * 10 volunteers participate in PART A to assess the PK of a single oral dose of Debio 1450 (tablet formulation) under varying gastric conditions * 40 volunteers participate in PART B to assess the safety, tolerability and PK of multiple ascending doses of Debio 1450, administered sequentially IV and orally, once or twice daily. * An additional 10 volunteers participate in PART C which is designed to assess the absolute bioavailability of various formulations of Debio 1450 under varying gastric conditions The dose administered during Part A is based on the safety, tolerability and PK data from study Debio 1450-102 \[NCT02162199\], a single ascending dose (SAD) study, in which single oral doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C based on the available safety and PK data from preceding cohorts.
Interventions
DRUGPlacebo IV Solution
A sterile IV solution of 5% dextrose in water
DRUGDebio 1450 IV Solution
A white to off-white powder (40 mg Debio 1450 per vial) to be reconstituted and formulated in a sterile IV solution of 5% dextrose in water
Placebo tablet or capsule, matching Debio 1450 coated tablet or capsule
DRUGDebio 1450 Tablet
Debio 1450 40 mg coated tablets
DRUGDebio 1450 Capsule
Debio 1450 40 mg capsules
DRUGDebio 1450 Oral Solution
Lyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water
DRUGPantoprazole
Pantoprazole 40 mg orally
Sponsors
Debiopharm International SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Meets protocol-specified criteria for qualification and/or contraception * Is willing and able to remain confined in the study unit for the entire duration of each treatment period and 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 a 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinically significant change from baseline in safety parameters | within 10 days post-dose | Categories: vital signs, 12-lead electrocardiogram (ECG), clinical laboratory parameters, adverse events, pulmonary function, physical examination, concomitant medication |
| Maximum observed plasma concentration (Cmax) of Debio 1450 (prodrug) and Debio 1452 (active moiety) | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
| Time of maximum observed plasma concentration (tmax) of Debio 1450 and Debio 1452 | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
| Area under the plasma concentration-time curve (AUC) of Debio 1450 and Debio 1452 | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
| Percentage of AUC(0-o) that is due to extrapolation beyond the last quantifiable concentration measurement (%AUCex) of Debio 1450 and Debio 1452 | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
| Elimination half-life (t1/2) of Debio 1450 and Debio 1452 | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
| Terminal elimination rate constant (Az) of Debio 1450 and Debio 1452 | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
| Mean residence time (MRT) of Debio 1450 and Debio 1452 | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
| Apparent clearance following oral administration (CL/F) of Debio 1450 and Debio 1452 | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
| Apparent volume of distribution of Debio 1450 and Debio 1452 during terminal phase (Vz/F) | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
| Cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae) | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
| Percentage of cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae%) | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
| Renal clearance following oral administration | within 60 hours post-dose, depending on the assessment schedule for the cohort | Categories: Placebo Tablet or Capsule, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution |
Countries
United States
Outcome results
None listed