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NCT01805024 · ClinicalTrials.gov registry record · Phase 1
Congenital Muscular Dystrophy Ascending Multiple Dose Cohort Study Analyzing Pharmacokinetics at Three Dose Levels In Children and Adolescents With Assessment of Safety and Tolerability of Omigapil (CALLISTO)
A Phase 1 study, sponsored by Santhera Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01805024 is a Phase 1 study that has completed, run by Santhera Pharmaceuticals. The registered enrollment target is 20 participants.
The verdict
NCT01805024, a Phase 1 study, has completed, sponsored by Santhera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of the study is to establish the pharmacokinetic profile of omigapil in paediatric and adolescent patients with CMD and to evaluate the safety and tolerability of omigapil. Funding source - FDA OOPD
Interventions
- DRUG Omigapil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-12 |
| Est. Completion | 2018-01-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01805024
The ClinicalTrials.gov registry entry for NCT01805024 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Santhera Pharmaceuticals, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omigapil is the first listed.
NCT01805024 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01805024 about?
NCT01805024 is a clinical study titled "Congenital Muscular Dystrophy Ascending Multiple Dose Cohort Study Analyzing Pharmacokinetics at Three Dose Levels In Children and Adolescents With Assessment of Safety and Tolerability of Omigapil (CALLISTO)". The purpose of the study is to establish the pharmacokinetic profile of omigapil in paediatric and adolescent patients with CMD and to evaluate the safety and tolerability of omigapil. Funding source - FDA OOPD
What is the current status of trial NCT01805024?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2014-12. Estimated completion is 2018-01-29.
What interventions are being tested in trial NCT01805024?
The interventions under investigation include: Omigapil (DRUG).
Who is sponsoring clinical trial NCT01805024?
This trial is sponsored by Santhera Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
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