A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
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 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.