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NCT02648438 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male Subjects
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02648438: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02648438 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02648438, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is an open-label,partially randomized, four-period study in healthy male subjects to assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered intravenously, orally and inhaled via two different dry powder inhalers (DPIs) and a pressurized meter-dose inhaler (pMDI)
Primary Outcome
For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594
Interventions
- DRUG AZD7594 Solution for infusion (150 μg intravenous formulation)
- DRUG AZD7594 Oral suspension (1200 μg oral formulation)
- DRUG AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler)
- DRUG AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler)
- DRUG AZD7594 Pressurized inhalation suspension (400 μg) by pMDI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-01-12 |
| Est. Completion | 2016-06-01 |
| Phase | Phase 1 |
What the finished NCT02648438 record still lists
NCT02648438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 5 interventions - of which AZD7594 Solution for infusion (150 μg intravenous formulation) is the first listed.
NCT02648438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02648438 about?
NCT02648438 is a clinical study titled "A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male Subjects". This is an open-label,partially randomized, four-period study in healthy male subjects to assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered intravenously, orally and inhaled via two different dry powder inhalers (DPIs) and a pressurized meter-dose inhaler ...
What is the current status of trial NCT02648438?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2016-01-12. Estimated completion is 2016-06-01.
What interventions are being tested in trial NCT02648438?
The interventions under investigation include: AZD7594 Solution for infusion (150 μg intravenous formulation) (DRUG), AZD7594 Oral suspension (1200 μg oral formulation) (DRUG), AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler) (DRUG), AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler) (DRUG), AZD7594 Pressurized inhalation suspension (400 μg) by pMDI (DRUG).
Who is sponsoring clinical trial NCT02648438?
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 NCT02648438's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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