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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AZTherapies, Inc.
• Collaborators: KCAS; Panax Clinical Research; Pharma Consulting Group AB
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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;

• History of hypersensitivity or allergies to any of the drug compound under investigation (cromolyn, ibuprofen, lactose, or magnesium stearate);

• History of clinically significant respiratory disorders and chronic respiratory disease with impaired respiratory effort or difficulty taking inhaled drugs (examples: COPD, emphysema);

• Abnormal pulmonary function test, defined for this protocol as: FEV1/FVC < 70% of the predicted value for the subject, when compared to reference values; AND FEV1 and FVC < 70% of predicted value when compared to reference values, indicating moderate to severe respiratory obstruction;

• Any other disease or condition, which, in the opinion of the investigator, would make the subject unsuitable for this study;

• Female subjects of reproductive potential with a positive pregnancy test (urine or serum) or who are pregnant or lactating.