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NCT03400488 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Japanese Men
A Phase 1 study of Coronary Artery Disease, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03400488: Completed Phase 1 study of Coronary Artery Disease, sponsored by AstraZeneca.
NCT03400488 is a Phase 1 study of Coronary Artery Disease that has completed, run by AstraZeneca. The registered enrollment target is 32 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03400488, a Phase 1 study of Coronary Artery Disease, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the novel compound, AZD5718 in healthy Japanese men. The results from this study will form the basis for decisions on future studies.
Primary Outcome
To assess the adverse events as a variable of safety and tolerability of AZD5718 following oral administration of single and multiple ascending doses. Adverse Events will be collected from the start of randomization throughout the treatment period up to and including the follow-up visit. Serious adverse events (SAEs) will be recorded from the time of informed consent.
Conditions Studied
Interventions
- DRUG AZD5718 oral suspension
- OTHER Placebo matching AZD5817 oral suspension
Study Locations (1)
California
- Research Site - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-01-16 |
| Est. Completion | 2018-06-12 |
| Phase | Phase 1 |
What the finished NCT03400488 record still lists
NCT03400488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which AZD5718 oral suspension is the first listed.
NCT03400488 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03400488 about?
NCT03400488 is a clinical study titled "A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Japanese Men". This is a Phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of the novel compound, AZD5718 in healthy Japanese men. The results from this study will form the basis for decisions on future studies.
What is the current status of trial NCT03400488?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-01-16. Estimated completion is 2018-06-12.
What conditions does trial NCT03400488 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT03400488?
The interventions under investigation include: AZD5718 oral suspension (DRUG), Placebo matching AZD5817 oral suspension (OTHER).
Who is sponsoring clinical trial NCT03400488?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03400488 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03400488's enrollment target sits among peer trials
32 197th of 219 higher than 23 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease 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.
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