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NCT02482324
A Phase I, Randomized, Open-Labeled Pharmacokinetic Study of ALZT-OP1 in Normal Healthy Volunteers
Phase 1 trial testing ALZT-OP1a in Healthy Volunteers in 26 participants. Completed in 1 July 2015.
1 July 2015
Quick facts
| Lead sponsor | AZTherapies, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Enrollment | 26 |
| Start date | 1 June 2015 |
| Primary completion | 1 July 2015 |
| Estimated completion | 1 July 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
AZTherapies, Inc. — full company profile →
Who can join
Adults 55 to 75, any sex, with Healthy Volunteers. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Non-compartmental plasma pharmacokinetics for ALZT-OP1a and ALZT-OP1b
Time frame: T=0 to 6 hours (0, 5, 10, 15, 30, 60, 120, 240, and 360 minutes)
* 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
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The roles of inflammation and immune mechanisms in Alzheimer's disease.
Van Eldik LJ, Carrillo MC, Cole PE, Feuerbach D, et al · · 2016 · cited 154× · PMID 29067297 · DOI 10.1016/j.trci.2016.05.001 -
Repurposed agents in the Alzheimer's disease drug development pipeline.
Bauzon J, Lee G, Cummings J. · · 2020 · cited 46× · PMID 32807237 · DOI 10.1186/s13195-020-00662-x -
Promising candidates from drug clinical trials: Implications for clinical treatment of Alzheimer's disease in China.
Cao Y, Yu F, Lyu Y, Lu X. · · 2022 · cited 16× · PMID 36457865 · DOI 10.3389/fneur.2022.1034243
Verify or expand the search:
- PubMed search for NCT02482324
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ALZT-OP1a
Trials testing the same drug.
- NCT02547818 — Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease · Phase 3 · completed
Other recruiting trials for Healthy Volunteers
Currently open trials in the same condition.
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- NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
- NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting
Other AZTherapies, Inc. trials
Trials by the same sponsor.
- NCT04428775 — A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease · Phase 2 · terminated
- NCT04570644 — Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers · Phase 1 · completed
- NCT02547818 — Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02482324 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AZTherapies, Inc.
- Last refreshed: 20 July 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02482324.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing