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NCT01757860 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects
A Phase 1 study of Drug Safety and Heart; Disease, Activity, sponsored by Cardiavent.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT01757860: Completed Phase 1 study of Drug Safety and Heart; Disease, Activity, sponsored by Cardiavent.
NCT01757860 is a Phase 1 study of Drug Safety and Heart; Disease, Activity that has completed, run by Cardiavent. The registered enrollment target is 34 participants, below the 95-participant average among 4 other Drug Safety trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01757860, a Phase 1 study of Drug Safety and Heart; Disease, Activity, has completed, sponsored by Cardiavent.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
Study Phase: Phase 1 Primary Objective: • To evaluate the safety and tolerability of single ascending oral doses of CARD-024 in healthy subjects Secondary Objectives: * To evaluate the pharmacokinetic (PK) profile of CARD-024 following ascending single oral doses of CARD-024 * To evaluate the effect of CARD-024 on cardiovascular indices including plasma renin activity (PRA) and blood pressure (BP), biological markers of activity, following ascending single oral doses of CARD-024
Primary Outcome
Adverse events such as nausea, vomiting, headache, muscle ache, neuralgia and patient overall tolerance to drug.
Conditions Studied
Interventions
- DRUG CARD-024
- OTHER Drug Carrier
Study Locations (1)
Michigan
- Jasper Clinic - Kalamazoo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
What the finished NCT01757860 record still lists
NCT01757860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 95-participant average among 4 other Drug Safety trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Drug Safety appearing as the primary indexed condition, and to 2 interventions - of which CARD-024 is the first listed.
NCT01757860 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01757860 about?
NCT01757860 is a clinical study titled "Safety and Pharmacokinetics Study of CARD-024 in Healthy Subjects". Study Phase: Phase 1 Primary Objective: • To evaluate the safety and tolerability of single ascending oral doses of CARD-024 in healthy subjects Secondary Objectives: * To evaluate the pharmacokinetic (PK) profile of CARD-024 following ascending single oral doses of CARD-024 * To evaluate the ef...
What is the current status of trial NCT01757860?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2011-09. Estimated completion is 2012-01.
What conditions does trial NCT01757860 study?
This clinical trial studies the following conditions: Drug Safety, Heart; Disease, Activity.
What interventions are being tested in trial NCT01757860?
The interventions under investigation include: CARD-024 (DRUG), Drug Carrier (OTHER).
Who is sponsoring clinical trial NCT01757860?
This trial is sponsored by Cardiavent, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01757860 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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