A Single Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/8/2014 |
| Start Date: | August 2014 |
| End Date: | October 2014 |
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Debio 1450 in Healthy Subjects
Debio 1450-103 is a study involving the use of a drug called Debio 1450. It is registered in
two parts (A and B). The primary purpose of Part A is to assess the pharmacokinetics of a
single oral dose of Debio 1450 (tablet formulation).
two parts (A and B). The primary purpose of Part A is to assess the pharmacokinetics of a
single oral dose of Debio 1450 (tablet formulation).
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 food, drink and
medications
- Voluntarily consents to participate and provides written informed consent prior to
any protocol-specific procedures
Exclusion Criteria:
- Has 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: 1) the safety or well-being of the participant
or study staff; 2) the safety or well-being of the participant's offspring (such as
through pregnancy or breast-feeding); 3) the analysis of results
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