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NCT02482324 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by AZTherapies.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT02482324: Completed Phase 1 study of Healthy Volunteers, sponsored by AZTherapies.
NCT02482324 is a Phase 1 study of Healthy Volunteers that has completed, run by AZTherapies. The registered enrollment target is 26 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02482324, a Phase 1 study of Healthy Volunteers, has completed, sponsored by AZTherapies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-labeled, cross-over design, pharmacokinetic study, to determine the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the active compounds, in healthy volunteers, aged 55-75, and in good general health.
Primary Outcome
* AUC (0-∞) (area under the curve from 0 to infinity) * AUC (0-t) (area under the curve from 0 to t hours where t is the last measured concentration * AUCPLASMA/AUCCSF (ratio at 5 min, 30 min, 2 hr and 4 hours) * CL/F (apparent total body clearance) * Cmax (maximum plasma concentration observed) * T ½ (half life) * Tmax (sampling time at which Cmax occurred) * Vd/F (apparent volume of distribution Plasma concentration-time profiles will be presented for both study drugs.
Conditions Studied
Interventions
- DEVICE Dry Powder Inhaler
- DRUG ALZT-OP1a
- DRUG ALZT-OP1b
Study Locations (1)
Florida
- Panax Clinical Research - Miami Lakes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-06 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT02482324 record still lists
NCT02482324 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which Dry Powder Inhaler is the first listed.
NCT02482324 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02482324 about?
NCT02482324 is a clinical study titled "Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers". This is an open-labeled, cross-over design, pharmacokinetic study, to determine the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the active compounds, in healthy volunteers, aged 55-75, and in ...
What is the current status of trial NCT02482324?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2015-06. Estimated completion is 2015-07.
What conditions does trial NCT02482324 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT02482324?
The interventions under investigation include: Dry Powder Inhaler (DEVICE), ALZT-OP1a (DRUG), ALZT-OP1b (DRUG).
Who is sponsoring clinical trial NCT02482324?
This trial is sponsored by AZTherapies, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02482324 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02482324's enrollment target sits among peer trials
26 201st of 283 higher than 81 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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