Healthy VolunteersPhase 1NCT02482324
Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers
A Phase 1 study testing ALZT-OP1a, ALZT-OP1b and Dry Powder Inhaler in people with Healthy Volunteers, run by AZTherapies, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ALZT-OP1a, ALZT-OP1b and Dry Powder Inhaler
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jul 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Open-Labeled Pharmacokinetic Study of ALZT-OP1 in Normal Healthy Volunteers
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.
Read the detailed description
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).
- Conditions
- Healthy Volunteers
- Being tested
- ALZT-OP1a, ALZT-OP1b, Dry Powder Inhaler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALZT-OP1aDrug
Also called Cromolyn, Intal
Mast cell stabilizer
ALZT-OP1bDrug
Also called ibuprofen
anti-inflammatory
Dry Powder InhalerDevice
The inhaler will be used to deliver ALZT-OP1a via oral inhalation for both days on study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: ALZT-OP1a; Drug: ALZT-OP1b; Device: Dry Powder Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
CSF samples will be collected at 5 time-points to measure levels of ALZT-OP1a and ALZT-OP1b in CSF.
Measured: T=0 to 4 hours (0, 5, 30, 120, and 240 minutes)
Number of Treatment Emergent Adverse Events (TEAE)
Safety will be evaluated based on the number, type, and frequency of treatment emergent adverse events. They will be individually presented for all subjects in data listings, and summarized in tables by treatment group and by treatment assignment. The AEs will be summarized and reported collectively based on information obtained through physical examination, ECG, and laboratory findings captured after dosing was initiated.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZTherapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Panax Clinical Research, Pharma Consulting Group AB, KCAS
- Responsible party
- Sponsor
- Investigators
- David Elmaleh, PhD, Study chair, Study SponsorDavid Brazier, BS, Study director, Study Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482324
- Sponsor's protocol ID
- AZT-002
- Status last verified
- Jul 2015
- First submitted
- 22 Jun 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Open-Labeled Pharmacokinetic Study of ALZT-OP1 in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02482324
- Acronym / sponsor ID
- AZT-002
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AZTherapies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Panax Clinical Research, Pharma Consulting Group AB, KCAS
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A-B | Other | Drug: ALZT-OP1a, Drug: ALZT-OP1b, Device: Dry Powder Inhaler12 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. |
| Treatment B-A | Other | Drug: ALZT-OP1a, Drug: ALZT-OP1b, Device: Dry Powder Inhaler12 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALZT-OP1aAlso: Cromolyn, IntalMast cell stabilizer | Drug | Treatment A-B, Treatment B-A |
| ALZT-OP1bAlso: ibuprofenanti-inflammatory | Drug | Treatment A-B, Treatment B-A |
| Dry Powder InhalerThe inhaler will be used to deliver ALZT-OP1a via oral inhalation for both days on study. | Device | Treatment A-B, Treatment B-A |
Primary outcome
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 Plasma concentration-time profiles will be presented for both study drugs.
2 secondary outcomes
Levels of ALZT-OP1a and ALZT-OP1b in cerebrospinal fluid (CSF)
Time frame: T=0 to 4 hours (0, 5, 30, 120, and 240 minutes)
Number of Treatment Emergent Adverse Events (TEAE)
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Elmaleh, PhD study chair
Study Sponsor
David Brazier, BS study director
Study Sponsor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALZT-OP1a, ALZT-OP1b and Dry Powder Inhaler in people with Healthy Volunteers, run by AZTherapies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.