A Single Dose Study of Debio 1450 in Healthy Subjects
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
The sponsor is trying to develop a medicine for infections that are not cured by regular
antibiotics. They have an experimental drug called Debio 1450 that may work. They need about
48 healthy adults to volunteer for this study.
This study looks at what the body does to the drug. It measures how the amount of drug in
blood and urine changes over time.
From the screening visit through the follow-up visit may be up to 40 days. Volunteers go to
the clinic in Baltimore for a screening visit. The study doctor chooses qualified volunteers
to participate or serve as alternates. Alternates might not actually complete the study
procedures.
The study doctor divides participants into groups of eight. Six receive Debio 1450 and 2
receive Placebo. The drug each participant receives is decided by chance - like flipping a
coin.
Eligible volunteers check into the clinic for testing and those chosen to participate remain
for a 5-day/ 4-night stay. The clinic serves standard meals, except when fasting is required.
Participants must stay at the clinic for the length of the study.
This study is a "dose escalation" study. That means that if no safety concerns come up a new
group starts. Each new group of eight participants receives more capsules.
The study product is contained in capsules. Each capsule contains either placebo or 40 mg
Debio 1450. After fasting overnight, the first two participants in the group receive their
capsules. One gets Debio 1450 and one gets Placebo. If these participants tolerate side
effects for 24 hours, the remaining six participants receive their assigned capsules.
The plan is to increase the dose for the next group. The study doctor reviews the
measurements collected from each group after three days. He may decide to repeat, increase,
or lower the dose or even stop the study. The most any participant receives is 800 mg in 20
capsules.