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NCT02214433 · ClinicalTrials.gov registry record · Phase 1
A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers
A Phase 1 study, sponsored by Debiopharm International.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT02214433: Completed Phase 1 study, sponsored by Debiopharm International.
NCT02214433 is a Phase 1 study that has completed, run by Debiopharm International. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02214433, a Phase 1 study, has completed, sponsored by Debiopharm International.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study 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.
Primary Outcome
Categories: vital signs, 12-lead electrocardiogram (ECG), clinical laboratory parameters, adverse events, pulmonary function, physical examination, concomitant medication
Interventions
- DRUG Placebo IV Solution
- DRUG Debio 1450 IV Solution
- DRUG Placebo Tablet or Capsule
- DRUG Debio 1450 Tablet
- DRUG Debio 1450 Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
What the finished NCT02214433 record still lists
NCT02214433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo IV Solution is the first listed.
NCT02214433 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02214433 about?
NCT02214433 is a clinical study titled "A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers". 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 thi...
What is the current status of trial NCT02214433?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2014-08. Estimated completion is 2015-02.
What interventions are being tested in trial NCT02214433?
The interventions under investigation include: Placebo IV Solution (DRUG), Debio 1450 IV Solution (DRUG), Placebo Tablet or Capsule (DRUG), Debio 1450 Tablet (DRUG), Debio 1450 Capsule (DRUG).
Who is sponsoring clinical trial NCT02214433?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02214433's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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