Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Debiopharm International. The registered enrollment target is 70 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02214433
The ClinicalTrials.gov registry entry for NCT02214433 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 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 5 interventions - of which Placebo IV Solution is the first listed.
NCT02214433 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.