Opioid-use DisorderPhase 1NCT04122755
Single Ascending Dose Study of ALA-1000
A Phase 1 study testing ALA-1000 and buprenorphine sublingual film in people with Opioid-use Disorder, run by Alar Pharmaceuticals Inc. at 1 site in United States.
Trial summary
An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of ALA-1000 in opioid-dependent subjects. To characterize the PK profile of ALA-1000 in 5 single ascending dose cohorts and a sixth cohort of single ALA-1000 after receiving buprenorphine sublingual films for 7 days. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- ALA-1000 and buprenorphine sublingual film
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 3 May 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Competent to provide informed consent.
- Voluntarily provide informed consent and Health Insurance Portability and Accounting Act (HIPAA) Authorization prior to any procedures or evaluations performed specifically for the sole purpose of the study.
- Male or female between 18 to 65 years of age inclusive at the screening visit.
- Meets DSM-5 criteria for Opioid Use Disorder (OUD) and is seeking treatment of OUD.
- Body Mass Index (BMI) ≥ 18 and ≤ 35 kg/m2 at screening visit.
- Female subjects of childbearing potential must agree to use a reliable method of birth control (e.g., total abstinence, condom and spermicide, intrauterine device (IUD), oral contraception which has been stable for 30 days) and at least 120 days after stopping the investigational product.
- Agree to withdraw from opiates for at least 12 hours prior to admission to clinical unit.
- Agree not to take any buprenorphine product (other than ALA-1000 and buprenorphine sublingual films during tolerability/induction period) during the study.
Who cannot join
- History or presence of a significant medical disease or disorder which, in the opinion of the investigator, increases the risk of the study drug or may confound the interpretation of study measures, as confirmed by screening laboratory results.
- Clinically significant abnormal findings on physical examination, vital signs, or Electrocardiogram (ECG). Defined as having a QTc (Fridericia) interval > 470 msec or any other clinically significant abnormalities at screening, check-in, or prior to administration of ALA-1000.
- Pregnant or lactating.
- History of suicidal behavior in the past 1 year or current suicidal ideation as per investigator judgement.
- Currently meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for substance use disorder, moderate or severe for any substance other than opioids, caffeine, or nicotine.
- Currently meets criteria for any unstable psychiatric disorder, including schizophrenia, schizoaffective, bipolar disorder (depression and stable bipolar disorder are not excluded if condition has been stable for at least 60 days).
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- Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS) as confirmed by Western Blot and viral load laboratory results.
- Acute active Hepatitis B or C as evidenced by positive serology and Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) >2 upper limit of normal (ULN)
- History of blood donation in excess of 450 mL within 30 days prior to Visit 1.
- Received treatment with an investigational drug or device within 90 days prior to Visit 1.
- Use of strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 30 days prior to Visit 1.
- Use of any new medication, vitamins, or supplements within 7 days prior to Visit.
- Hypersensitivity or allergy to buprenorphine or other opioids which, in the opinion of the investigator, would compromise subject safety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Ascending Dose, Open-Label Study Evaluating the Safety, Tolerability, And Pharmacokinetics of ALA-1000 in Opioid-Dependent Individuals
An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of ALA-1000 in opioid-dependent subjects. To characterize the PK profile of ALA-1000 in 5 single ascending dose cohorts and a sixth cohort of single ALA-1000 after receiving buprenorphine sublingual films for 7 days.
Read the detailed description
The study will include opioid-dependent subjects who have been receiving stable, orally administered buprenorphine for at least 2 weeks or buprenorphine naïve subjects who will be stabilized on orally administered buprenorphine for 3 days prior to ALA-1000 administration.
All subjects will be washed off of oral buprenorphine for 7 days prior to ALA-1000 administration except Cohort 6 which will receive ALA-1000 administration after 7 days of buprenorphine sublingual film dosing.
The subsequent cohorts will be initiated after safety and PK information from the preceding cohorts is available.
The expected maximum duration of participation for each subject is 192 days approximately, consisting of up to a 7-day screening period, up to a 31-day residential phase, and up to a 154-day nonresidential period.
- Conditions
- Opioid-use Disorder
- Being tested
- ALA-1000, buprenorphine sublingual film
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALA-1000Drug
Also called Depot Buprenorphine Formulation
Blood sample for PK analysis are collected before and post single injection of ALA-1000 (Day1) according to the schedule of procedures. Subjects remain in the residential phase through Day21 for safety assessment.
buprenorphine sublingual filmDrug
ALA-1000 injection after 7 days of buprenorphine sublingual film dosing. Blood sample for PK analysis are collected before and post sublingual buprenorphine dosing on Day-1
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Experimental | Subjects receive a single subcutaneous injection of 1-fold ALA-1000 dose (first in human dose). Receives: Drug: ALA-1000 |
| Cohort2 | Experimental | Subjects receive a single subcutaneous injection of 2-fold ALA-1000 dose Receives: Drug: ALA-1000 |
| Cohort3 | Experimental | Subjects receive a single subcutaneous injection of 4.7-fold ALA-1000 dose Receives: Drug: ALA-1000 |
| Cohort4 | Experimental | Subjects receive a single subcutaneous injection of 9.4-fold ALA-1000 dose Receives: Drug: ALA-1000 |
| Cohort5 | Experimental | Subjects receive a single subcutaneous injection of 18.8-fold ALA-1000 dose Receives: Drug: ALA-1000 |
| Cohort6 | Experimental | Subjects receive a single subcutaneous injection of 18.8-fold ALA-1000 dose after 7 days of buprenorphine sublingual film dosing Receives: Drug: ALA-1000; Drug: buprenorphine sublingual film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs will be summarized by treatment overall, by severity, and by relationship to ALA-1000. Serious AEs and AEs leading to discontinuation of study drug will also be presented.
Measured: Baseline (prior to dosing) through the End of Study (Day175), or Early termination
Change of vital signs will be assessed in subjects receiving ALA-1000.
Vital signs including blood pressure, pulse rate, respiration rate, pulse oximetry and temperature. Systolic and diastolic blood pressure will be assessed while supine and standing. Pulse oximetry will be monitored continuously for 24 hours post injection to assess for any signs/symptoms of respiratory depression.
Measured: Baseline (prior to dosing) through the End of Study (Day175), or Early termination
Chang of clinical laboratory assessments (biochemistry, hematology and urinalysis) will be assessed in subjects receiving ALA-1000.
Samples will be collected for laboratory tests, including hematology, serum chemistry, urinalysis, serum/urine pregnancy test (conducted for females of childbearing potential only), and urine drug screen, to assess the safety of subjects.
Measured: Baseline (prior to dosing) through the End of Study (Day175), or Early termination
Change of ECG parameter of QTcF interval will be assessed in subjects receiving ALA-1000
Measured: Baseline (prior to dosing) through the End of Study (Day175), or Early termination
A standard physical examination will be performed to monitor the safety in subjects receiving ALA-1000
The examination will include assessment of skin, head, ears, eyes, nose, throat, neck, thyroid, lungs, heart, cardiovascular, abdomen, lymph nodes, and musculoskeletal system/extremities.
Measured: Baseline (prior to dosing) to the End of Study (Day175), or Early termination
Injection site assessment will be conducted to monitor the safety in subjects receiving ALA-1000
Injection site assessment including pain, tenderness, induration, erythema/redness, and swelling. If an infection develops at the injection site, the subject will be withdrawn from the study.
Measured: From the end of ALA-1000 injection through the End of Study (Day175), or Early termination
Concomitant medications will be reviewed and documented to monitor the safety in subjects receiving ALA-1000
The medication name, dose, frequency, date, and indication for use must be recorded
Measured: Prior to dosing through the End of Study (Day175), or Early termination
AUC (area under the plasma concentration-time curve) for subjects receive ALA-1000 injection
Measured: Prior to ALA-1000 injection through the End of Study (Day175), or Early termination
Cmax (maximum observed plasma concentration) for subjects receive ALA-1000 injection
Measured: Prior to ALA-1000 injection through the End of Study (Day175), or Early termination
Tmax (time to maximum concentration) for subjects receive ALA-1000 injection
Measured: Prior to ALA-1000 injection through the End of Study (Day175), or Early termination
t1/2 (time to half plasma concentration) for subjects receive ALA-1000 injection
Measured: Prior to ALA-1000 injection through the End of Study (Day175), or Early termination
Secondary outcomes (3)
Change of opioid withdrawal symptoms will be assessed using Clinical Opiate Withdrawal Scale (COWS) for subjects receive ALA-1000 injection
Opioid withdrawal symptoms will be measured using COWS scores. Score: 5- 1 2 = mild; 1 3-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal
Measured: Baseline (prior to dosing) through the End of Study (Day175), or Early termination
Change of suicidal ideation will be assessed using Columbia-Suicide Severity Rating Scale (C-SSRS) for subjects receive ALA-1000 injection
Suicidal ideation scores will be reported using C-SSRS. The suicidal ideation scale identifies behaviors and thoughts that are associated with an increased risk of suicidal actions in the future. Score: 5- 1 2 = mild; 1 3-24 = moderate; 25-36 = moderately severe; more than 36 = severe suicidal ideation.
Measured: Screening through the End of Study (Day175), or Early termination
Assessment of the abstinence by urine toxicology results negative for opioids in subjects received ALA-1000 injection.
Measured: Screening through the End of Study (Day175), or Early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start16 Sep 2019
- Primary completion3 May 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alar Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erin Tireman, Study director, Innovative Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122755
- Sponsor's protocol ID
- A1-19-P01
- Status last verified
- Dec 2021
- First submitted
- 8 Oct 2019
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose, Open-Label Study Evaluating the Safety, Tolerability, And Pharmacokinetics of ALA-1000 in Opioid-Dependent Individuals
- ClinicalTrials.gov ID
- NCT04122755
- Acronym / sponsor ID
- A1-19-P01
- Conditions
- Opioid-use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Alar Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 10 Oct 2019 (actual)
- 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.
An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of ALA-1000 in opioid-dependent subjects. To characterize the PK profile of ALA-1000 in 5 single ascending dose cohorts and a sixth cohort of single ALA-1000 after receiving buprenorphine sublingual films for 7 days.
Detailed description
The study will include opioid-dependent subjects who have been receiving stable, orally administered buprenorphine for at least 2 weeks or buprenorphine naïve subjects who will be stabilized on orally administered buprenorphine for 3 days prior to ALA-1000 administration.
All subjects will be washed off of oral buprenorphine for 7 days prior to ALA-1000 administration except Cohort 6 which will receive ALA-1000 administration after 7 days of buprenorphine sublingual film dosing.
The subsequent cohorts will be initiated after safety and PK information from the preceding cohorts is available.
The expected maximum duration of participation for each subject is 192 days approximately, consisting of up to a 7-day screening period, up to a 31-day residential phase, and up to a 154-day nonresidential period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort1 | Experimental | Drug: ALA-1000Subjects receive a single subcutaneous injection of 1-fold ALA-1000 dose (first in human dose). |
| Cohort2 | Experimental | Drug: ALA-1000Subjects receive a single subcutaneous injection of 2-fold ALA-1000 dose |
| Cohort3 | Experimental | Drug: ALA-1000Subjects receive a single subcutaneous injection of 4.7-fold ALA-1000 dose |
| Cohort4 | Experimental | Drug: ALA-1000Subjects receive a single subcutaneous injection of 9.4-fold ALA-1000 dose |
| Cohort5 | Experimental | Drug: ALA-1000Subjects receive a single subcutaneous injection of 18.8-fold ALA-1000 dose |
| Cohort6 | Experimental | Drug: ALA-1000, Drug: buprenorphine sublingual filmSubjects receive a single subcutaneous injection of 18.8-fold ALA-1000 dose after 7 days of buprenorphine sublingual film dosing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Competent to provide informed consent.
- Voluntarily provide informed consent and Health Insurance Portability and Accounting Act (HIPAA) Authorization prior to any procedures or evaluations performed specifically for the sole purpose of the study.
- Male or female between 18 to 65 years of age inclusive at the screening visit.
- Meets DSM-5 criteria for Opioid Use Disorder (OUD) and is seeking treatment of OUD.
- Body Mass Index (BMI) ≥ 18 and ≤ 35 kg/m2 at screening visit.
Key exclusion criteria (13 listed)
- History or presence of a significant medical disease or disorder which, in the opinion of the investigator, increases the risk of the study drug or may confound the interpretation of study measures, as confirmed by screening laboratory results.
- Clinically significant abnormal findings on physical examination, vital signs, or Electrocardiogram (ECG). Defined as having a QTc (Fridericia) interval > 470 msec or any other clinically significant abnormalities at screening, check-in, or prior to administration of ALA-1000.
- Pregnant or lactating.
- History of suicidal behavior in the past 1 year or current suicidal ideation as per investigator judgement.
- Currently meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for substance use disorder, moderate or severe for any substance other than opioids, caffeine, or nicotine.
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 |
|---|---|---|
| ALA-1000Also: Depot Buprenorphine FormulationBlood sample for PK analysis are collected before and post single injection of ALA-1000 (Day1) according to the schedule of procedures. Subjects remain in the residential phase through Day21 for safety assessment. | Drug | Cohort1, Cohort2, Cohort3, Cohort4, Cohort5, Cohort6 |
| buprenorphine sublingual filmALA-1000 injection after 7 days of buprenorphine sublingual film dosing. Blood sample for PK analysis are collected before and post sublingual buprenorphine dosing on Day-1 | Drug | Cohort6 |
Primary outcome
Incidence of AEs will be summarized by treatment overall, by severity, and by relationship to ALA-1000. Serious AEs and AEs leading to discontinuation of study drug will also be presented.
Time frame: Baseline (prior to dosing) through the End of Study (Day175), or Early termination
Change of vital signs will be assessed in subjects receiving ALA-1000.
Time frame: Baseline (prior to dosing) through the End of Study (Day175), or Early termination
Vital signs including blood pressure, pulse rate, respiration rate, pulse oximetry and temperature. Systolic and diastolic blood pressure will be assessed while supine and standing. Pulse oximetry will be monitored continuously for 24 hours post injection to assess for any signs/symptoms of respiratory depression.
Chang of clinical laboratory assessments (biochemistry, hematology and urinalysis) will be assessed in subjects receiving ALA-1000.
Time frame: Baseline (prior to dosing) through the End of Study (Day175), or Early termination
Samples will be collected for laboratory tests, including hematology, serum chemistry, urinalysis, serum/urine pregnancy test (conducted for females of childbearing potential only), and urine drug screen, to assess the safety of subjects.
Change of ECG parameter of QTcF interval will be assessed in subjects receiving ALA-1000
Time frame: Baseline (prior to dosing) through the End of Study (Day175), or Early termination
A standard physical examination will be performed to monitor the safety in subjects receiving ALA-1000
Time frame: Baseline (prior to dosing) to the End of Study (Day175), or Early termination
The examination will include assessment of skin, head, ears, eyes, nose, throat, neck, thyroid, lungs, heart, cardiovascular, abdomen, lymph nodes, and musculoskeletal system/extremities.
Injection site assessment will be conducted to monitor the safety in subjects receiving ALA-1000
Time frame: From the end of ALA-1000 injection through the End of Study (Day175), or Early termination
Injection site assessment including pain, tenderness, induration, erythema/redness, and swelling. If an infection develops at the injection site, the subject will be withdrawn from the study.
Concomitant medications will be reviewed and documented to monitor the safety in subjects receiving ALA-1000
Time frame: Prior to dosing through the End of Study (Day175), or Early termination
The medication name, dose, frequency, date, and indication for use must be recorded
AUC (area under the plasma concentration-time curve) for subjects receive ALA-1000 injection
Time frame: Prior to ALA-1000 injection through the End of Study (Day175), or Early termination
Cmax (maximum observed plasma concentration) for subjects receive ALA-1000 injection
Time frame: Prior to ALA-1000 injection through the End of Study (Day175), or Early termination
Tmax (time to maximum concentration) for subjects receive ALA-1000 injection
Time frame: Prior to ALA-1000 injection through the End of Study (Day175), or Early termination
t1/2 (time to half plasma concentration) for subjects receive ALA-1000 injection
Time frame: Prior to ALA-1000 injection through the End of Study (Day175), or Early termination
3 secondary outcomes
Change of opioid withdrawal symptoms will be assessed using Clinical Opiate Withdrawal Scale (COWS) for subjects receive ALA-1000 injection
Time frame: Baseline (prior to dosing) through the End of Study (Day175), or Early termination
Change of suicidal ideation will be assessed using Columbia-Suicide Severity Rating Scale (C-SSRS) for subjects receive ALA-1000 injection
Time frame: Screening through the End of Study (Day175), or Early termination
Assessment of the abstinence by urine toxicology results negative for opioids in subjects received ALA-1000 injection.
Time frame: Screening through the End of Study (Day175), or Early termination
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 Dec 2021.
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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.
Erin Tireman study director
Innovative Clinical Research
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 ALA-1000 and buprenorphine sublingual film in people with Opioid-use Disorder, run by Alar 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 8 inclusion and 13 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 Dec 2021. 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?
Incidence of AEs will be summarized by treatment overall, by severity, and by relationship to ALA-1000. Serious AEs and AEs leading to discontinuation of study drug will also be presented. (time frame: Baseline (prior to dosing) through the End of Study (Day175), or Early termination). The study lists 11 primary outcomes in all. 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 30 Dec 2021.