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NCT00950105 · ClinicalTrials.gov registry record · Phase 1
Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)
A Phase 1 study of Crohn's Disease, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00950105 is a Phase 1 study of Crohn's Disease that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 30 participants, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00950105, a Phase 1 study of Crohn's Disease, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will be conducted in healthy male or female subjects using a double-blind, randomized, placebo-controlled, single-dose design. Up to 30 subjects will be enrolled; 3 healthy subjects in Cohorts 1 and 2 (2 active, 1 placebo) and 8 healthy subjects in Cohorts 3 to 5 (6 active, 2 placebo). The following CPSI-2364 doses are proposed: 1 mg, 10 mg, 30 mg, 90 mg, and 270 mg.Safety will be evaluated throughout the study and include physical examinations, vital signs assessments, 12-lead electrocardiograms (ECGs), routine clinical laboratory tests (including blood chemistry, hematology, coagulation, and urinalysis), and adverse event (AE) assessments. Vital sign assessments and 12-lead ECGs will be performed repeatedly over the 24-hour observation period. Venous blood samples will be taken at specified intervals and tested for the presence of CPSI-2364.
Conditions Studied
Interventions
- DRUG CPSI-2364 or placebo
Study Locations (1)
Kansas
- Quintiles - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-07 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00950105
The ClinicalTrials.gov registry entry for NCT00950105 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (99% lower). The listed sponsor is Ferring Pharmaceuticals, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which CPSI-2364 or placebo is the first listed.
NCT00950105 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
Frequently Asked Questions
What is clinical trial NCT00950105 about?
NCT00950105 is a clinical study titled "Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)". This study will be conducted in healthy male or female subjects using a double-blind, randomized, placebo-controlled, single-dose design. Up to 30 subjects will be enrolled; 3 healthy subjects in Cohorts 1 and 2 (2 active, 1 placebo) and 8 healthy subjects in Cohorts 3 to 5 (6 active, 2 placebo). Th...
What is the current status of trial NCT00950105?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2009-07. Estimated completion is 2009-10.
What conditions does trial NCT00950105 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT00950105?
The interventions under investigation include: CPSI-2364 or placebo (DRUG).
Who is sponsoring clinical trial NCT00950105?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00950105 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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