Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2019-09-16
2021-05-03
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort1
Subjects receive a single subcutaneous injection of 1-fold ALA-1000 dose (first in human dose).
ALA-1000
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.
Cohort2
Subjects receive a single subcutaneous injection of 2-fold ALA-1000 dose
ALA-1000
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.
Cohort3
Subjects receive a single subcutaneous injection of 4.7-fold ALA-1000 dose
ALA-1000
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.
Cohort4
Subjects receive a single subcutaneous injection of 9.4-fold ALA-1000 dose
ALA-1000
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.
Cohort5
Subjects receive a single subcutaneous injection of 18.8-fold ALA-1000 dose
ALA-1000
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.
Cohort6
Subjects receive a single subcutaneous injection of 18.8-fold ALA-1000 dose after 7 days of buprenorphine sublingual film dosing
ALA-1000
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 film
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
Interventions
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ALA-1000
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 film
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Male or female between 18 to 65 years of age inclusive at the screening visit.
4. Meets DSM-5 criteria for Opioid Use Disorder (OUD) and is seeking treatment of OUD.
5. Body Mass Index (BMI) ≥ 18 and ≤ 35 kg/m2 at screening visit.
6. 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.
7. Agree to withdraw from opiates for at least 12 hours prior to admission to clinical unit.
8. Agree not to take any buprenorphine product (other than ALA-1000 and buprenorphine sublingual films during tolerability/induction period) during the study.
Exclusion Criteria
2. 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.
3. Pregnant or lactating.
4. History of suicidal behavior in the past 1 year or current suicidal ideation as per investigator judgement.
5. 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.
6. 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).
7. Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS) as confirmed by Western Blot and viral load laboratory results.
8. Acute active Hepatitis B or C as evidenced by positive serology and Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) \>2 upper limit of normal (ULN)
9. History of blood donation in excess of 450 mL within 30 days prior to Visit 1.
10. Received treatment with an investigational drug or device within 90 days prior to Visit 1.
11. Use of strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 30 days prior to Visit 1.
12. Use of any new medication, vitamins, or supplements within 7 days prior to Visit.
13. Hypersensitivity or allergy to buprenorphine or other opioids which, in the opinion of the investigator, would compromise subject safety.
18 Years
65 Years
ALL
No
Sponsors
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Alar Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Erin Tireman
Role: STUDY_DIRECTOR
Innovative Clinical Research
Locations
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Innovative Clinical Research
Miami, Florida, United States
Countries
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Other Identifiers
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A1-19-P01
Identifier Type: -
Identifier Source: org_study_id