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Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers

NCT02482324 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-07-21

No results posted yet for this 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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ALZT-OP1a

Mast cell stabilizer

DRUG

ALZT-OP1b

anti-inflammatory

DEVICE

Dry Powder Inhaler

The inhaler will be used to deliver ALZT-OP1a via oral inhalation for both days on study.

Sponsors & Collaborators

  • Panax Clinical Research

    collaborator OTHER

  • Pharma Consulting Group AB

    collaborator INDUSTRY

  • KCAS

    collaborator UNKNOWN

  • AZTherapies, Inc.

    lead INDUSTRY

Principal Investigators

  • David Elmaleh, PhD · Study Sponsor

  • David Brazier, BS · Study Sponsor

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02482324 on ClinicalTrials.gov