Status:
COMPLETED
A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers
Lead Sponsor:
Debiopharm International SA
Conditions:
Bacterial Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02214433
Start Date
August 1 2014
End Date
February 1 2015
Last Update
February 25 2015
Active Locations (1)
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1
Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225