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

NCT02482324 | Completed Phase 1

• 1 other identifier: AZT-002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Non-compartmental plasma pharmacokinetics for ALZT-OP1a and ALZT-OP1b

  * 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.

  T=0 to 6 hours (0, 5, 10, 15, 30, 60, 120, 240, and 360 minutes)

Secondary Outcomes (2)

• Levels of ALZT-OP1a and ALZT-OP1b in cerebrospinal fluid (CSF)

  T=0 to 4 hours (0, 5, 30, 120, and 240 minutes)

• Number of Treatment Emergent Adverse Events (TEAE)

  2 days

Study Arms (2)

Treatment A-B

OTHER

12 subjects will receive a single oral inhaled dose of ALZT-OP1a, via dry powder inhaler, and a single oral tablet dose of ALZT-OP1b on Day 1, and two doses of ALZT-OP1a and ALZT-OP1b on Day 2, within two minutes of each other. All subjects will have plasma collected for PK analysis and 6 of 12 consented subjects from this group will provide CSF samples for analysis. CSF collected on Day 1 only.

Drug: ALZT-OP1a; Drug: ALZT-OP1b; Device: Dry Powder Inhaler

Treatment B-A

OTHER

12 subjects will receive two oral inhaled doses of ALZT-OP1a, via dry powder inhaler, and two oral tablet doses of ALZT-OPb, within two minutes of each other, on Day 1, and single doses of ALZT-OP1a and ALZT-OP1b on Day 2. All subjects will have plasma collected for PK analysis and 6 of 12 consented subjects from this group will provide CSF samples for analysis. CSF collected on Day 1 only.

Drug: ALZT-OP1a; Drug: ALZT-OP1b; Device: Dry Powder Inhaler

Interventions

ALZT-OP1a DRUG

Mast cell stabilizer

Also known as: Cromolyn, Intal

Treatment A-B; Treatment B-A

ALZT-OP1b DRUG

anti-inflammatory

Also known as: ibuprofen

Treatment A-B; Treatment B-A

Dry Powder Inhaler DEVICE

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

Treatment A-B; Treatment B-A

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide a signed written informed consent;
• Age 55-75 inclusive;
• ECG within normal limits;
• Body mass index (BMI) ≥ 18 kg/m2 and ≤ 30 kg/m2;
• Negative urine drug screen for selected drugs of abuse at screening;
• Negative for hepatitis and HIV at screening;
• Good general health, as determined by medical history, physical examination, and clinical laboratory testing;
• Willingness to stay in the unit overnight for the duration of the study;
• Consent for CSF collection (for those in CSF group).

You may not qualify if:

• Current smokers, or ex-smokers with a remote history (\> 100 pack/year);
• Clinically significant medical conditions;
• History of ECG abnormalities;
• Symptomatic viral infection, or suspicion thereof (including rhinitis) in the last 14 days prior to dosing;
• Signs of active pulmonary infection or other pulmonary inflammatory conditions, even in absence of febrile episodes, in the last 14 days;
• History or presence of disease in the kidneys and/or heart, lungs, liver, gastrointestinal tract, endocrine organs or other conditions such as metabolic disease known to interfere with the absorption, distribution, metabolism, and excretion of drugs;
• Malignancy, regardless of location;
• Autoimmune disorders such as (but not limited to) lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or sarcoidosis;
• Investigational agents are prohibited one month prior to entry and for the duration of the trial;
• Currently taking medications known to be CYP2C9 inducers (i.e. carbamazepine and rifampicin);
• Currently taking cromolyn, or have taken cromolyn, within the past 30 days;
• NSAID use (products containing ibuprofen while on study);
• Aspirin, or products containing aspirin, while on study;
• Allergy or hypersensitivity to cromolyn (also known as Intal®, Nasalcrom®, etc.);
• Allergy or hypersensitivity to ibuprofen (Advil®, Motrin®, Nuprin®, etc.) or aspirin, including Stevens-Johnson syndrome;

Sponsors & Collaborators

• AZTherapies, Inc.: lead
• Panax Clinical Research: collaborator
• Pharma Consulting Group AB: collaborator
• KCAS: collaborator

Study Sites (1)

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

MeSH Terms

Interventions

Cromolyn Sodium; Ibuprofen; Dry Powder Inhalers

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Nebulizers and Vaporizers; Equipment and Supplies

Study Officials

• David Elmaleh, PhD

  Study Sponsor

  STUDY CHAIR

• David Brazier, BS

  Study Sponsor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 26, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

US (1)