| ID | Type | Description | Link |
|---|---|---|---|
| 217595 | Other Identifier | CRO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Period 1 Debio 1450 IV Solution | Experimental | Part A Debio 1450 IV solution infused over two hours on Day 1 after fasting |
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| Part A Period 2 Debio 1450 Tablet | Experimental | Debio 1450 Tablet oral dosing once on Day 5, after fasting |
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| Part A Period 3 Debio 1450 Tablet | Experimental | Debio 1450 Tablet oral dosing once on Day 9, 30 minutes after a high calorie, high fat breakfast, after fasting |
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| Part A Period 4 Debio 1450 Tablet | Experimental | After preparation with Pantoprazole, Pantoprazole taken with Debio 1450 Tablet oral dosing once on Day 14, after fasting |
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| Part B Placebo All Cohorts | Placebo Comparator | Placebo IV solution on days 1-5 and then Placebo Tablet or Capsule on Days 6-10, according to the cohort dosing schedule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo IV Solution | Drug | A sterile IV solution of 5% dextrose in water |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | within 60 hours post-dose, depending on the assessment schedule for the cohort |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Wittke, MD | Debiopharm International SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Early Phase Clinical Unit | Baltimore | Maryland | 21225 | United States |
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| Part B Debio 1450 Cohort 1 | Experimental | Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Tablet, once daily on days 6-10 |
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| Part B Debio 1450 Cohort 2a | Experimental | Debio 1450 IV solution, once daily on day 1 |
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| Part B Debio 1450 Cohort 3 | Experimental | Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10 |
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| Part B Debio 1450 Cohort 4 | Experimental | Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10 |
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| Part B Debio 1450 Cohort 2b | Experimental | Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Capsule, once daily on days 6-10 |
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| Part C Debio 1450 | Experimental | 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). |
|
| Debio 1450 IV Solution |
| Drug |
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 |
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| Placebo Tablet or Capsule | Drug | Placebo tablet or capsule, matching Debio 1450 coated tablet or capsule |
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| Debio 1450 Tablet | Drug | Debio 1450 40 mg coated tablets |
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| Debio 1450 Capsule | Drug | Debio 1450 40 mg capsules |
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| Debio 1450 Oral Solution | Drug | Lyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water |
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| Pantoprazole | Drug | Pantoprazole 40 mg orally |
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| 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | within 60 hours post-dose, depending on the assessment schedule for the cohort |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002214 | Capsules |
| C000657127 | afabicin |
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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