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NCT02645253 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7594 Inhaled Formulation in Healthy Japanese Men
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT02645253: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02645253 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02645253, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics \[PD\]) and how the body affects the drug (pharmacokinetics \[PK\]) when AZD7594 is given as single and multiple ascending doses once daily by inhalation to healthy male Japanese subjects, compared with placebo (non-active drug)
Primary Outcome
To assess the safety and tolerability of single and multiple doses of AZD7594
Interventions
- DRUG AZD7594 inhalation powder (200 μg)
- DRUG AZD7594 inhalation powder (400 μg)
- DRUG AZD7594 pressurized inhalation suspension (200 μg)
- DRUG AZD7594 placebo inhalation powder
- DRUG AZD7594 placebo pressurized inhalation suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2016-01-12 |
| Est. Completion | 2016-04-17 |
| Phase | Phase 1 |
What the finished NCT02645253 record still lists
NCT02645253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which AZD7594 inhalation powder (200 μg) is the first listed.
NCT02645253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02645253 about?
NCT02645253 is a clinical study titled "A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7594 Inhaled Formulation in Healthy Japanese Men". This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics \[PD\]) and how the body affects the drug (pharmacokinetics \[PK\]) when AZD7594 is given as single and multiple a...
What is the current status of trial NCT02645253?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2016-01-12. Estimated completion is 2016-04-17.
What interventions are being tested in trial NCT02645253?
The interventions under investigation include: AZD7594 inhalation powder (200 μg) (DRUG), AZD7594 inhalation powder (400 μg) (DRUG), AZD7594 pressurized inhalation suspension (200 μg) (DRUG), AZD7594 placebo inhalation powder (DRUG), AZD7594 placebo pressurized inhalation suspension (DRUG).
Who is sponsoring clinical trial NCT02645253?
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 NCT02645253's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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