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NCT02162199 · ClinicalTrials.gov registry record · Phase 1
A Single Dose Study of Debio 1450 in Healthy Subjects
A Phase 1 study, sponsored by Debiopharm International.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT02162199 is a Phase 1 study that has completed, run by Debiopharm International. The registered enrollment target is 48 participants.
The verdict
NCT02162199, a Phase 1 study, has completed, sponsored by Debiopharm International.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Debio 1450
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-06 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02162199
The ClinicalTrials.gov registry entry for NCT02162199 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02162199 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02162199 about?
NCT02162199 is a clinical study titled "A Single Dose Study of Debio 1450 in Healthy Subjects". 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 th...
What is the current status of trial NCT02162199?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2014-06. Estimated completion is 2014-10.
What interventions are being tested in trial NCT02162199?
The interventions under investigation include: Placebo (DRUG), Debio 1450 (DRUG).
Who is sponsoring clinical trial NCT02162199?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
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