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NCT01046357 · ClinicalTrials.gov registry record · Phase 1
A Study in Healthy Volunteers to Assess the Tolerability and Blood Levels of a Single Dose of AZD7687
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT01046357: Completed Phase 1 study, sponsored by AstraZeneca.
NCT01046357 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 64 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
NCT01046357, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single ascending dose study in healthy male volunteers conducted at a single centre. The effect of food on the pharmacokinetics of AZD7687 will also be studied. The study will consist of two parts, a dose escalation part and a food interaction part. The two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation. Each subject will receive dose only once, except for the volunteers included in the dose steps repeated for food interaction.
Interventions
- DRUG Placebo
- DRUG AZD7687
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2009-11 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
What the finished NCT01046357 record still lists
NCT01046357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 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.
NCT01046357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01046357 about?
NCT01046357 is a clinical study titled "A Study in Healthy Volunteers to Assess the Tolerability and Blood Levels of a Single Dose of AZD7687". This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single ascending dose study in healthy male volunteers conducted at a single centre. The effect of food on the pharmacokinetics of AZD7687 will also be studied. The study will consist of two parts, a dose escalation pa...
What is the current status of trial NCT01046357?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2009-11. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01046357?
The interventions under investigation include: Placebo (DRUG), AZD7687 (DRUG).
Who is sponsoring clinical trial NCT01046357?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01046357's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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