AnesthesiaPhase 1NCT02027155
Phase I Rising-dose Study to Assess Tolerability, Safety, Pharmacokinetics, Pharmacodynamics of AR09
A Phase 1 study testing AR09 solution in people with Anesthesia, run by Arbor Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This will be a randomized, double-blind, placebo-controlled, rising-dose study of single IV doses of AR09 in healthy subjects. Each infusion will occur over 10 minutes. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- AR09 solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Apr 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
- Males/females between 18 to 50 years of age, inclusive;
- Body mass index 18 to 30 kg/m2, inclusive.
- All females must have a negative serum beta human chorionic gonadotropin test result at screening and a negative urine pregnancy test result at baseline. Female subjects must be either post-menopausal, surgically sterile or using an acceptable method of contraception. Acceptable surgical sterilization techniques are hysterectomy, bilateral tubal ligation with surgery at least 6 months prior to dosing and bilateral oophorectomy with surgery at least 2 months prior to dosing. Acceptable methods of contraception are an intrauterine device, contraceptive implant, oral contraceptive (stable dose of the same hormonal contraceptive product for at least 12 weeks prior to dosing), a vasectomized partner and a double-barrier method (condom + spermicide / diaphragm + spermicide).
- Willing and able to provide voluntary, written informed consent.
Who cannot join
- Acute illness within 2 weeks prior to dosing;
- History of any chronic illness or evidence of significant organic or psychiatric disease on medical history or physical examination which, in the opinion of the Investigator would confound the study results or present a risk to the subject;
- History of any clinically significant pulmonary conditions, within the last 2 years requiring admission to the hospital;
- Spirometry forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) ratio less than 70%;
- If female, pregnant or lactating;
- Clinically significant illness or abnormality on physical examination, or ECG, including measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QTc interval) >440 msec, on Screening or pre-dose 12-lead ECG;
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- Resting heart rate while awake < 45 or > 90 b/m;
- Laboratory value(s) outside the laboratory reference range considered clinically significant (clinical chemistry, hematology, coagulation, ACTH, urinalysis, or pregnancy test).
- Presence of type I or type II diabetes;
- History of a severe allergic reaction to any drug or multiple food/drug allergies;
- Subjects with a formal diagnosis obstructive sleep apnea or having a score of >3 on the STOP-Bang questionnaire (see Appendix 4);
- Reported chronic (regular use for >1 month) use of medication of any kind (except contraceptives as described in the inclusion criteria), unless approved by the Sponsor;
- Reported use of any prescription drug within 14 days prior to dosing, any non-prescription drug or vitamin within 7 days prior to dosing, any known enzyme-inducer, enzyme-inhibitor, or other investigational drug within 30 days prior to dosing, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of dosing, unless approved by the Sponsor; hormonal contraceptive will be permitted if the subject has been using it for at least 12 weeks prior to dosing;
- History of alcohol or illicit drug abuse within the past two years, or current reported average alcohol intake > two alcoholic drinks per day (e.g., more than 24 oz. of beer, 10 oz. of wine, or 3 oz. of hard liquor);
- Regular use of tobacco or nicotine containing products within 1 year of study entry;
- Average consumption of ≥ 6 caffeine containing beverages per day;
- Consumption of alcohol within 72 hours prior to dosing, or a positive qualitative urine drug or cotinine screen, or positive oral screen for the presence of alcohol;
- Consumption of herbal supplements, grapefruit or grapefruit juice within 14 days before dosing;
- Blood donation of approximately 400 mL or more within 4 weeks or plasma donation within 2 weeks prior to dosing;
- Received an investigational product within 30 days of first dose in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Unit
Durham, North Carolina, 27710
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Rising-dose Study to Assess the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single IV Doses of AR09 in Healthy Subjects
This will be a randomized, double-blind, placebo-controlled, rising-dose study of single IV doses of AR09 in healthy subjects. Each infusion will occur over 10 minutes.
Read the detailed description
Each subject will complete Screening, Baseline, Treatment, and Follow-Up Phases. The Screening Phase will be conducted on an outpatient basis within 30 days, but no less than 3 days, prior to the start of the Baseline Phase. The Baseline Phase will consist of clinical research unit (CRU) admission and final qualification assessments. The Treatment Phase will be comprised of dosing on Day 1, post-treatment safety and pharmacodynamic assessments, and blood and urine collection. Subjects may be discharged approximately 24 hours after study drug administration on Day 2, provided the Modified Aldrete Score and all designated discharge criteria are clinically acceptable to the Investigator. The Follow-Up Phase will occur on Study Day 5 (± 1 day).
- Conditions
- Anesthesia
- Being tested
- AR09 solution, placebo
- Keywords
- healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR09 solutionDrug
Also called investigational product
moderate levels of sedation
placeboDrug
Also called Sterile Saline, United States Pharmacopeial (USP)
Sterile Saline, USP
| Study group | Role | What they receive |
|---|---|---|
| AR09 solution | Active comparator | AR09, Randomized, Double-blind, Placebo-controlled, Rising-dose Study to Assess the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single IV Doses of AR09 in Healthy Subjects Receives: Drug: AR09 solution; Drug: placebo |
| Placebo (for AR09 solution) | Placebo comparator | Placebo; normal saline Receives: Drug: AR09 solution; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose (MTD) of single IV doses of AR09
Incidence of treatment-emergent adverse events (AE) by dose, including changes in temperature, respiratory rate, respiratory function at specified intervals post-dosing up to 24 hours.
- Treatment-emergent changes in 12-lead electrocardiogram (ECG) recordings compared to pre-dose at specified intervals post-dosing and at Follow-Up including changes in heart rate and rhythm by dose at specified intervals post-dosing through 24 hours.
- Treatment-emergent changes in group mean systolic and group mean diastolic blood pressure by dose at specified intervals post-dosing through 24 hours.
- Treatment-emergent changes in clinical laboratory tests at specified intervals post-dosing and at Follow-Up.
- Adrenocorticotropic hormone (ACTH) test to evaluate adrenal function pre and post dose.
Measured: 4 hours
Secondary outcomes (1)
Characterize the single dose pharmacokinetics (PK) of IV doses of AR09 and its predominate metabolite, ADX892
Individual and group plasma concentration-time curves of AR09 and ADX892 (metabolite);
- Individual and group maximum concentration (Cmax) and time to observed peak plasma concentration (Tmax);
- For AR09, individual and group estimates of area under the curve (AUC) AUC 0-t, AUC 0-∞, terminal phase rate constant (λz), t1/2, systemic clearance (CL), and volumes of distribution (Vz and Vss).
- For ADX892, individual and group estimates of AUC 0-t, AUC 0-∞, terminal phase rate constant (λz), and t1/2. Additional PK parameters for the metabolite, such as metabolite to parent ratios will be calculated on the basis of the available data.
- Compartmental pharmacokinetic analysis may be employed depending upon the appearance of the AR09 and ADX892 plasma concentration-time profiles.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Study stopping criteria was met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David MacLeod, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027155
- Sponsor's protocol ID
- AR09.001
- Other IDs
- AR09.001
- Status last verified
- Apr 2022
- First submitted
- 29 Dec 2013
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, Rising-dose Study to Assess the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single IV Doses of AR09 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02027155
- Acronym / sponsor ID
- AR09.001
- Conditions
- Anesthesia
- Keywords
- healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopping criteria was met
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Arbor Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Jan 2014 (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 will be a randomized, double-blind, placebo-controlled, rising-dose study of single IV doses of AR09 in healthy subjects. Each infusion will occur over 10 minutes.
Detailed description
Each subject will complete Screening, Baseline, Treatment, and Follow-Up Phases. The Screening Phase will be conducted on an outpatient basis within 30 days, but no less than 3 days, prior to the start of the Baseline Phase. The Baseline Phase will consist of clinical research unit (CRU) admission and final qualification assessments. The Treatment Phase will be comprised of dosing on Day 1, post-treatment safety and pharmacodynamic assessments, and blood and urine collection. Subjects may be discharged approximately 24 hours after study drug administration on Day 2, provided the Modified Aldrete Score and all designated discharge criteria are clinically acceptable to the Investigator. The Follow-Up Phase will occur on Study Day 5 (± 1 day).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR09 solution | Active comparator | Drug: AR09 solution, Drug: placeboAR09, Randomized, Double-blind, Placebo-controlled, Rising-dose Study to Assess the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single IV Doses of AR09 in Healthy Subjects |
| Placebo (for AR09 solution) | Placebo comparator | Drug: AR09 solution, Drug: placeboPlacebo; normal saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males/females between 18 to 50 years of age, inclusive;
- Body mass index 18 to 30 kg/m2, inclusive.
- All females must have a negative serum beta human chorionic gonadotropin test result at screening and a negative urine pregnancy test result at baseline. Female subjects must be either post-menopausal, surgically sterile or using an acceptable method of contraception. Acceptable surgical sterilization techniques are hysterectomy, bilateral tubal ligation with surgery at least 6 months prior to dosing and bilateral oophorectomy with surgery at least 2 months prior to dosing. Acceptable methods of contraception are an intrauterine device, contraceptive implant, oral contraceptive (stable dose of the same hormonal contraceptive product for at least 12 weeks prior to dosing), a vasectomized partner and a double-barrier method (condom + spermicide / diaphragm + spermicide).
- Willing and able to provide voluntary, written informed consent.
Key exclusion criteria (20 listed)
- Acute illness within 2 weeks prior to dosing;
- History of any chronic illness or evidence of significant organic or psychiatric disease on medical history or physical examination which, in the opinion of the Investigator would confound the study results or present a risk to the subject;
- History of any clinically significant pulmonary conditions, within the last 2 years requiring admission to the hospital;
- Spirometry forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) ratio less than 70%;
- If female, pregnant or lactating;
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 |
|---|---|---|
| AR09 solutionAlso: investigational productmoderate levels of sedation | Drug | AR09 solution, Placebo (for AR09 solution) |
| placeboAlso: Sterile Saline, United States Pharmacopeial (USP)Sterile Saline, USP | Drug | AR09 solution, Placebo (for AR09 solution) |
Primary outcome
Determine the maximum tolerated dose (MTD) of single IV doses of AR09
Time frame: 4 hours
Incidence of treatment-emergent adverse events (AE) by dose, including changes in temperature, respiratory rate, respiratory function at specified intervals post-dosing up to 24 hours. * Treatment-emergent changes in 12-lead electrocardiogram (ECG) recordings compared to pre-dose at specified intervals post-dosing and at Follow-Up including changes in heart rate and rhythm by dose at specified intervals post-dosing through 24 hours. * Treatment-emergent changes in group mean systolic and group mean diastolic blood pressure by dose at specified intervals post-dosing through 24 hours. * Treatment-emergent changes in clinical laboratory tests at specified intervals post-dosing and at Follow-Up. * Adrenocorticotropic hormone (ACTH) test to evaluate adrenal function pre and post dose.
1 secondary outcome
Characterize the single dose pharmacokinetics (PK) of IV doses of AR09 and its predominate metabolite, ADX892
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Study stopping criteria was met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
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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 MacLeod, MD principal investigator
Duke University
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 AR09 solution in people with Anesthesia, run by Arbor Pharmaceuticals, 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 4 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: stopped early, as of the sponsor's last update on 13 Apr 2022. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Study stopping criteria was met). Results are not available in the source record.
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?
Determine the maximum tolerated dose (MTD) of single IV doses of AR09 (time frame: 4 hours). 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 13 Apr 2022.