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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 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 64 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01046357
The ClinicalTrials.gov registry entry for NCT01046357 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 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.
NCT01046357 reports 0 study locations.
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.
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