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NCT03136991 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Safety Tolerability and Pharmacokinetics of AZD4831 to Treat Cardiovascular Disease
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT03136991 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 38 participants.
The verdict
NCT03136991, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
This is a Phase I study to investigate the safety and tolerability of AZD4831 in healthy male participants, conducted at a single center. The results from this study will form the basis for decisions on future studies. Another purpose of this dose escalation study is to find out the right dose of the experimental drug to be given to study participants in future studies. Even though there were no harmful effects seen in the animals tested, investigator does not know what side effects the experimental drug might cause in humans. However, site personnel managing the study participants will be blinded to the extent possible and as long as possible to minimize any impact on data collection. Study participants will be blinded to treatment allocation. The study will be conducted in healthy participants to avoid interference from disease processes or other drugs. The participants will stay at the study center during the whole dosing period and until 48 hours post final dose.
Interventions
- DRUG Placebo
- DRUG AZD4831
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-05-15 |
| Est. Completion | 2017-11-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03136991
The ClinicalTrials.gov registry entry for NCT03136991 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03136991 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03136991 about?
NCT03136991 is a clinical study titled "A Phase I, Safety Tolerability and Pharmacokinetics of AZD4831 to Treat Cardiovascular Disease". This is a Phase I study to investigate the safety and tolerability of AZD4831 in healthy male participants, conducted at a single center. The results from this study will form the basis for decisions on future studies. Another purpose of this dose escalation study is to find out the right dose of th...
What is the current status of trial NCT03136991?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2017-05-15. Estimated completion is 2017-11-22.
What interventions are being tested in trial NCT03136991?
The interventions under investigation include: Placebo (DRUG), AZD4831 (DRUG).
Who is sponsoring clinical trial NCT03136991?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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