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NCT01493596 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability and Pharmacokinetic Study of CPP-115
A Phase 1 study, sponsored by Catalyst Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01493596: Completed Phase 1 study, sponsored by Catalyst Pharmaceuticals.
NCT01493596 is a Phase 1 study that has completed, run by Catalyst Pharmaceuticals. The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01493596, a Phase 1 study, has completed, sponsored by Catalyst Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
Primary Objective: • To evaluate the safety and tolerability of ascending single oral doses of CPP-115 Secondary Objective: • To determine the pharmacokinetic profiles of CPP-115 following administration of a ascending single oral doses
Primary Outcome
Number of subjects with clinically significant changes in vital signs, ECG abnormalities changes of cardiac rhythm, serious or severe AEs, and/or clinically significant changes in clinical laboratory evaluations.
Interventions
- DRUG Placebo
- DRUG CPP-115
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT01493596 record still lists
NCT01493596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01493596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01493596 about?
NCT01493596 is a clinical study titled "A Safety, Tolerability and Pharmacokinetic Study of CPP-115". Primary Objective: • To evaluate the safety and tolerability of ascending single oral doses of CPP-115 Secondary Objective: • To determine the pharmacokinetic profiles of CPP-115 following administration of a ascending single oral doses
What is the current status of trial NCT01493596?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2011-12. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01493596?
The interventions under investigation include: Placebo (DRUG), CPP-115 (DRUG).
Who is sponsoring clinical trial NCT01493596?
This trial is sponsored by Catalyst Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01493596's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 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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