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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
70
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
Early Phase Clinical Unit
Baltimore, Maryland, United States
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
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