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NCT01328821 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics (PK) of CTP-499
A Phase 1 study, sponsored by Concert Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT01328821: Completed Phase 1 study, sponsored by Concert Pharmaceuticals.
NCT01328821 is a Phase 1 study that has completed, run by Concert Pharmaceuticals. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01328821, a Phase 1 study, has completed, sponsored by Concert Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CTP-499 following single dose administration.
Primary Outcome
Assessments will include monitoring of adverse events, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12 lead ECGs, and physical examination findings. Safety data will be summarized using descriptive statistics for all subjects who receive at least 1 dose. Adverse events will be summarized by frequency. Abnormal laboratory and physical exam findings will be summarized by dose and treatment.
Interventions
- DRUG CTP-499
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
What the finished NCT01328821 record still lists
NCT01328821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which CTP-499 is the first listed.
NCT01328821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01328821 about?
NCT01328821 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics (PK) of CTP-499". The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CTP-499 following single dose administration.
What is the current status of trial NCT01328821?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2011-03. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01328821?
The interventions under investigation include: CTP-499 (DRUG).
Who is sponsoring clinical trial NCT01328821?
This trial is sponsored by Concert Pharmaceuticals, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01328821's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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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