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Miami Lakes, Florida 33014


Purpose:

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.


Study summary:

This is an open-labeled, cross-over design, pharmacokinetic study, where 24 subjects will be randomly assigned to receive treatment regimen A-B or B-A on two consecutive days of dosing. Two dosing groups are planned for the study : - Group 1 (n=12) - Group 2 (n=12) Each group will be admitted to the Phase I Unit the evening before dosing and will initiate dosing the next morning for 2-days of consecutive treatment (A-B, or B-A). Both groups will undergo identical study related procedures, except those subjects that consent to CSF collection on Day 1 of dosing. Dose regimen A consists of a single inhaled oral dose of ALZT-OP1a via dry powder inhaler + a single oral tablet dose of ALZT-OP1b. Dose regimen B consists of two oral inhaled doses of ALZT-OP1a, not more than 2 minutes apart, via dry powder inhaler + two oral tablet doses of ALZT-OP1b. Plasma Collection, All Subjects (n=24) 1 mL blood samples will be collected at T: 0, 5, 10, 15, 30, 1 hr, 2 hr, 4 hr, and 6 hours, following ALZT-OP1 administration (Days 1 and 2). CSF Collection, Sub-group (n=12) A sub-group of 12 subjects will be consented for CSF collection. 1 mL of CSF will be collected at T: 0, 5 min, 30 min, 2 hr, and 4 hours, following ALZT-OP1 administration (Day 1 only).


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.


NCT ID:

NCT02482324


Primary Contact:

Study Chair
David Elmaleh, PhD
Study Sponsor


Backup Contact:

N/A


Location Contact:

Miami Lakes, Florida 33014
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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