HealthyPhase 1NCT02723669
Relative Bioavailability of AR10 Compared to Reference Product
A Phase 1 study testing AR10 and acetylcysteine in people with Healthy, run by Arbor Pharmaceuticals, Inc..
Trial summary
This study evaluates the relative bioavailability of Acetylcysteine Effervescent Tablets (AR10) and Reference N-acetylcysteine. Patients will receive both products in an Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover design. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AR10 and acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to May 2014
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects (males or females) between 18 - 50 years of age inclusive.
- Body weight at least 154 pounds (70 kg) and a Body Mass Index no greater than 30 kg/m2.
- Healthy as determined by medical history, clinical examination, and laboratory examination performed within 30 days prior to admission for the first period of the study.
- Subjects willing and able to provide a written informed consent, HIPPA and to adhere to the protocol requirements.
- If female and of childbearing potential (defined as a pre-menopausal female who is biologically capable of becoming pregnant), the subject must agree to remain abstinent or practice a medically acceptable form of contraception from screening until the close out visit of the clinical study. Acceptable forms of contraception include intrauterine devices, implantable devices, and barrier methods. If a barrier method is chosen, a double barrier (e.g., condom plus foam) is required.
- Negative beta human chorionic gonadotropin test, consistent with no pregnancy (females only).
- Non-smokers
Who cannot join
- Known hypersensitivity, allergy, idiosyncratic reaction or adverse reaction to acetylcysteine, its excipients, and other related compounds with similar chemical characteristics or any severe allergic reaction to any drug or multiple food/drug allergies.
- History or current evidence of clinically significant medical condition including, but not limited to, hepatic, renal, cardiac, vascular, gastrointestinal, or thyroid disease, diabetes, epilepsy, respiratory or hematological disease, acute narrow angle glaucoma, or psychiatric disorder that, in the opinion of the Principal Investigator, would confound the study results or present a risk to the subject.
- Subjects are to be without symptoms of nausea and/or vomiting. Subjects with a history of chronic nausea/vomiting are excluded. Subjects who had an acute illness/condition and have not had any nausea and/or vomiting episodes in the past two weeks may be screened provided they are medically cleared from the acute illness/condition involving nausea and/or vomiting episode(s).
- Existence of any surgical or medical condition that in the judgment of Principal Investigator might interfere with the absorption, distribution, metabolism, or elimination of the investigational product.
- Any clinically significant abnormality in the electrocardiogram (12 lead ECG).
- Laboratory values that are considered clinically significant (clinical chemistry, hematology, coagulation, urinalysis, or pregnancy test) - Note: In the event of any parameter lying outside of the normal range, the sample may be repeated once. This value will be accepted if it lies within the normal range.
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- Consumption of grapefruit juice/grapefruit within 14 days prior to Period I admission.
- Use of alcohol or caffeine containing products within 72 hours of each dose of °History or presence of alcoholism or drug abuse within 1 year of study participation.
- Known or suspected carcinoma.
- Presence of the disease markers of the human immunodeficiency virus (HIV) 1 or 2, and hepatitis B or C viruses.
- Positive serum test for drug(s) of abuse testing (amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol, morphine, and cocaine, and alcohol).
- History of intake/administration of any investigational treatment in a clinical study within the last 30 days prior to the onset of the study admission in Period I.
- History of significant blood loss (≥ 350 mL) due to any reason, including blood donation, within the last 12 weeks prior to admission in Period I of the study.
- Intake/administration of any enzyme-modifying drugs or drugs that might increase or decrease acetylcysteine levels within 30 days of investigational product administration, or over-the-counter (OTC) drugs including vitamins and natural supplements within 21 days of the first dose of Investigational Product administration and throughout study unless approved by the Principal Investigator or Sponsor.
- Requirement of special diet preventing consumption of standard, healthy meals during the in-clinic portions of the study. In such cases, subject selection will be at the discretion of the Principal Investigator in discussion with Medical Monitor, if required.
- Any subject who, in the opinion of the Principal Investigator, cannot or may not follow instructions.
- Difficulty in swallowing a liquid solution.
- Female subjects with a self-reported history of anemia during menstrual cycle which may coincide with any of the dosing day(s) during the study period.
- Pregnant and lactating females.
- Employee of the Sponsor, Clinical site, or Clinical research organization.
About this study
Official title: Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study to Determine the Relative Bioavailability of AR10 (Acetylcysteine Effervescent Tablets) Compared to Reference Product in Healthy, Adult Subjects, Fasting
This study evaluates the relative bioavailability of Acetylcysteine Effervescent Tablets (AR10) and Reference N-acetylcysteine. Patients will receive both products in an Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover design.
Read the detailed description
An Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study Relative Bioavailability Study. The present study is intended to compare and evaluate the relative bioavailability of a single 11 gram dose of AR10 (acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g]), and the reference Listed Drug (acetylcysteine solution; oral 20% [200 mg/mL] of American Pharmaceutical Partners) in healthy adult, human subjects under fasting conditions. A balanced block randomization schedule will be generated before the start of dosing.
- Conditions
- Healthy
- Being tested
- AR10, acetylcysteine
- Keywords
- Relative Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR10Drug
Also called acetylcysteine
effervescent tablet
acetylcysteineDrug
Also called reference product
oral solution
| Study group | Role | What they receive |
|---|---|---|
| AR10 | Experimental | AR10 acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g) Receives: Drug: AR10 |
| acetylcysteine | Active comparator | acetylcysteine solution; oral 20% (200 mg/mL) Receives: Drug: acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Area Under the Curve (AUC) profiles of the two formulations of acetylcysteine to determine the Relative Bioavailability
To compare AUC of a single 11 gram dose of AR10 acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g), and the Reference Listed Drug (acetylcysteine solution; oral 20% [200 mg/mL] from American Pharmaceutical Partners) in a minimum of 24 healthy adult, human subjects under fasting conditions, to establish relative bioavailability.
Measured: 10 days
Comparison of Maximum Plasma Concentration (Cmax) profiles of the two formulations of acetylcysteine to determine the Relative Bioavailability
To compare Cmax of a single 11 gram dose of AR10 acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g), and the Reference Listed Drug (acetylcysteine solution; oral 20% [200 mg/mL] from American Pharmaceutical Partners) in a minimum of 24 healthy adult, human subjects under fasting conditions, to establish relative bioavailability.
Measured: 10 days
Secondary outcomes (1)
The safety and tolerability of AR10 and the reference product, as measured by treatment-emergent adverse events (AEs), concomitant medications, vital signs (pulse, temperature and respiratory rate), and assessment of well-being.
To compare the safety and tolerability of AR10 and the reference product, as measured by treatment-emergent adverse events (AEs), concomitant medications, vital signs (pulse, temperature and respiratory rate), and assessment of well-being.
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tania D Johnson, RN, BSN, Study director, Arbor Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723669
- Sponsor's protocol ID
- AR10.001
- Status last verified
- Mar 2016
- First submitted
- 17 Mar 2016
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Greene SC, Noonan PK, Sanabria C, Peacock WF. Effervescent N-Acetylcysteine Tablets versus Oral Solution N-Acetylcysteine in Fasting Healthy Adults: An Open-Label, Randomized, Single-Dose, Crossover, Relative Bioavailability Study. Curr Ther Res Clin Exp. 2016 Jun 27;83:1-7. doi: 10.1016/j.curtheres.2016.06.001. eCollection 2016.
PubMed 27668024
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study to Determine the Relative Bioavailability of AR10 (Acetylcysteine Effervescent Tablets) Compared to Reference Product in Healthy, Adult Subjects, Fasting
- ClinicalTrials.gov ID
- NCT02723669
- Acronym / sponsor ID
- AR10.001
- Conditions
- Healthy
- Keywords
- Relative Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Mar 2016 (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 study evaluates the relative bioavailability of Acetylcysteine Effervescent Tablets (AR10) and Reference N-acetylcysteine. Patients will receive both products in an Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover design.
Detailed description
An Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study Relative Bioavailability Study. The present study is intended to compare and evaluate the relative bioavailability of a single 11 gram dose of AR10 (acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g]), and the reference Listed Drug (acetylcysteine solution; oral 20% [200 mg/mL] of American Pharmaceutical Partners) in healthy adult, human subjects under fasting conditions. A balanced block randomization schedule will be generated before the start of dosing.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR10 | Experimental | Drug: AR10AR10 acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g) |
| acetylcysteine | Active comparator | Drug: acetylcysteineacetylcysteine solution; oral 20% (200 mg/mL) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects (males or females) between 18 - 50 years of age inclusive.
- Body weight at least 154 pounds (70 kg) and a Body Mass Index no greater than 30 kg/m2.
- Healthy as determined by medical history, clinical examination, and laboratory examination performed within 30 days prior to admission for the first period of the study.
- Subjects willing and able to provide a written informed consent, HIPPA and to adhere to the protocol requirements.
- If female and of childbearing potential (defined as a pre-menopausal female who is biologically capable of becoming pregnant), the subject must agree to remain abstinent or practice a medically acceptable form of contraception from screening until the close out visit of the clinical study. Acceptable forms of contraception include intrauterine devices, implantable devices, and barrier methods. If a barrier method is chosen, a double barrier (e.g., condom plus foam) is required.
Key exclusion criteria (20 listed)
- Known hypersensitivity, allergy, idiosyncratic reaction or adverse reaction to acetylcysteine, its excipients, and other related compounds with similar chemical characteristics or any severe allergic reaction to any drug or multiple food/drug allergies.
- History or current evidence of clinically significant medical condition including, but not limited to, hepatic, renal, cardiac, vascular, gastrointestinal, or thyroid disease, diabetes, epilepsy, respiratory or hematological disease, acute narrow angle glaucoma, or psychiatric disorder that, in the opinion of the Principal Investigator, would confound the study results or present a risk to the subject.
- Subjects are to be without symptoms of nausea and/or vomiting. Subjects with a history of chronic nausea/vomiting are excluded. Subjects who had an acute illness/condition and have not had any nausea and/or vomiting episodes in the past two weeks may be screened provided they are medically cleared from the acute illness/condition involving nausea and/or vomiting episode(s).
- Existence of any surgical or medical condition that in the judgment of Principal Investigator might interfere with the absorption, distribution, metabolism, or elimination of the investigational product.
- Any clinically significant abnormality in the electrocardiogram (12 lead ECG).
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 |
|---|---|---|
| AR10Also: acetylcysteineeffervescent tablet | Drug | AR10 |
| acetylcysteineAlso: reference productoral solution | Drug | acetylcysteine |
Primary outcome
Comparison of Area Under the Curve (AUC) profiles of the two formulations of acetylcysteine to determine the Relative Bioavailability
Time frame: 10 days
To compare AUC of a single 11 gram dose of AR10 acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g), and the Reference Listed Drug (acetylcysteine solution; oral 20% [200 mg/mL] from American Pharmaceutical Partners) in a minimum of 24 healthy adult, human subjects under fasting conditions, to establish relative bioavailability.
Comparison of Maximum Plasma Concentration (Cmax) profiles of the two formulations of acetylcysteine to determine the Relative Bioavailability
Time frame: 10 days
To compare Cmax of a single 11 gram dose of AR10 acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g), and the Reference Listed Drug (acetylcysteine solution; oral 20% [200 mg/mL] from American Pharmaceutical Partners) in a minimum of 24 healthy adult, human subjects under fasting conditions, to establish relative bioavailability.
1 secondary outcome
The safety and tolerability of AR10 and the reference product, as measured by treatment-emergent adverse events (AEs), concomitant medications, vital signs (pulse, temperature and respiratory rate), and assessment of well-being.
Time frame: 12 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 30 Mar 2016.
- Derived from this study: PubMed 27668024Greene SC, Noonan PK, Sanabria C, Peacock WF. Effervescent N-Acetylcysteine Tablets versus Oral Solution N-Acetylcysteine in Fasting Healthy Adults: An Open-Label, Randomized, Single-Dose, Crossover, Relative Bioavailability Study. Curr Ther Res Clin Exp. 2016 Jun 27;83:1-7. doi: 10.1016/j.curtheres.2016.06.001. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
Tania D Johnson, RN, BSN study director
Arbor Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AR10 and acetylcysteine in people with Healthy, run by Arbor Pharmaceuticals, Inc..
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 7 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 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of Area Under the Curve (AUC) profiles of the two formulations of acetylcysteine to determine the Relative Bioavailability (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02723669, which also lists 1 linked publication.
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 30 Mar 2016.