A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers
Bacterial Infections
About this trial
This is an interventional basic science trial for Bacterial Infections focused on measuring Antibiotic, Antibiotic Resistant Bacterial Infection
Eligibility Criteria
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:
- 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
Sites / Locations
- Early Phase Clinical Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Part A Period 1 Debio 1450 IV Solution
Part A Period 2 Debio 1450 Tablet
Part A Period 3 Debio 1450 Tablet
Part A Period 4 Debio 1450 Tablet
Part B Placebo All Cohorts
Part B Debio 1450 Cohort 1
Part B Debio 1450 Cohort 2a
Part B Debio 1450 Cohort 3
Part B Debio 1450 Cohort 4
Part B Debio 1450 Cohort 2b
Part C Debio 1450
Part A Debio 1450 IV solution infused over two hours on Day 1 after fasting
Debio 1450 Tablet oral dosing once on Day 5, after fasting
Debio 1450 Tablet oral dosing once on Day 9, 30 minutes after a high calorie, high fat breakfast, after fasting
After preparation with Pantoprazole, Pantoprazole taken with Debio 1450 Tablet oral dosing once on Day 14, after fasting
Placebo IV solution on days 1-5 and then Placebo Tablet or Capsule on Days 6-10, according to the cohort dosing schedule
Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Tablet, once daily on days 6-10
Debio 1450 IV solution, once daily on day 1
Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10
Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10
Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Capsule, once daily on days 6-10
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).