A Phase 1 interventional study of Placebo IV Solution and Debio 1450 IV Solution in Bacterial Infections, sponsored by Debiopharm International SA. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-25.
Sponsored by Debiopharm International SA (part of Debiopharm) · Phase 1, Interventional, and Basic science
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:
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.
665 studies on the registry are indexed under Bacterial Infections; 99 are open to participants now.
This study's enrollment of 70 is below the median of 80 across 410 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Debiopharm International SA is the lead sponsor of 51 studies on the registry; 6 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
Part A Debio 1450 IV solution infused over two hours on Day 1 after fasting
Drug: Debio 1450 IV Solution
Debio 1450 Tablet oral dosing once on Day 5, after fasting
Drug: Debio 1450 Tablet
Debio 1450 Tablet oral dosing once on Day 9, 30 minutes after a high calorie, high fat breakfast, after fasting
Drug: Debio 1450 Tablet
After preparation with Pantoprazole, Pantoprazole taken with Debio 1450 Tablet oral dosing once on Day 14, after fasting
Drug: Debio 1450 Tablet · Drug: Pantoprazole
Placebo IV solution on days 1-5 and then Placebo Tablet or Capsule on Days 6-10, according to the cohort dosing schedule
Drug: Placebo IV Solution · Drug: Placebo Tablet or Capsule
Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Tablet, once daily on days 6-10
Drug: Debio 1450 IV Solution · Drug: Debio 1450 Tablet
Debio 1450 IV solution, once daily on day 1
Drug: Debio 1450 IV Solution
Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10
Drug: Debio 1450 IV Solution · Drug: Debio 1450 Capsule
Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10
Drug: Debio 1450 IV Solution · Drug: Debio 1450 Capsule
Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Capsule, once daily on days 6-10
Drug: Debio 1450 IV Solution · Drug: Debio 1450 Capsule
Debio 1450 (IV formulation in Period 1, capsule formulation in Periods 2, 4 and 5 (with Pantoprazole), and Debio 1450 oral solution in Period 3).
Drug: Debio 1450 IV Solution · Drug: Debio 1450 Capsule · Drug: Debio 1450 Oral Solution · Drug: Pantoprazole
A sterile IV solution of 5% dextrose in water
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
Debio 1450 40 mg coated tablets
Debio 1450 40 mg capsules
Lyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water
Pantoprazole 40 mg orally
Number of participants with clinically significant change from baseline in safety parameters
Categories: vital signs, 12-lead electrocardiogram (ECG), clinical laboratory parameters, adverse events, pulmonary function, physical examination, concomitant medication
Time frame: within 10 days post-dose
Maximum observed plasma concentration (Cmax) of Debio 1450 (prodrug) and Debio 1452 (active moiety)
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
Time of maximum observed plasma concentration (tmax) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
Area under the plasma concentration-time curve (AUC) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
Percentage of AUC(0-o) that is due to extrapolation beyond the last quantifiable concentration measurement (%AUCex) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
Elimination half-life (t1/2) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
Terminal elimination rate constant (Az) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
Mean residence time (MRT) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
Apparent clearance following oral administration (CL/F) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
Apparent volume of distribution of Debio 1450 and Debio 1452 during terminal phase (Vz/F)
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
Cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae)
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
Percentage of cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae%)
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
Renal clearance following oral administration
Categories: Placebo Tablet or Capsule, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Afabicin · Pantoprazole