Overview

Single Ascending Dose Study of ALA-1000

Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alar Pharmaceuticals Inc.
Treatments:
Buprenorphine
Criteria
Inclusion Criteria:

1. Competent to provide informed consent.

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:

1. 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.

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.