Study of a Novel Subcutaneous Depot Formulation of Buprenorphine

• Status: Completed
• Trial end date: 2018-06-07
• Target enrollment: 0
• Participant gender: All

Summary

INDV-6200 is being developed for the treatment of opioid dependency and is expected to provide sustained buprenorphine plasma concentrations. The study will be done in healthy volunteers and will administer a non-therapeutic dose of INDV-6200. Study Period 1 will evaluate the oral tolerability of sublingual (SL) buprenorphine dosed over 3 days. Period 2 will administer the investigational medicinal product (IMP) or volume matched placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indivior Inc.
• Treatments: Buprenorphine; Naltrexone

Criteria

Inclusion Criteria:

1. Healthy males or non-pregnant, non-lactating females

2. Body mass index of 18.0-33.0 kg/m2 or, if outside the range, considered not clinically significant by the Investigator

3. Willing and able to communicate and participate in the whole study

4. Provide written informed consent prior to any study specific procedures

5. Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment, ECG, and laboratory investigations

6. Males and females must agree to use an adequate method of contraception

7. Tolerated SL buprenorphine and nalorex during Period 1

Exclusion Criteria:

1. Medical history of opioid-related adverse reactions

2. History of clinically significant alcohol/drug abuse in the previous 5 years

3. Received any investigational medicinal product within the previous 3 months

4. Study site employees or immediate family members of study site or sponsor employee

5. Previously enrolled in the study

6. Regular alcohol consumption in males greater than 21 units/week and females greater than 14 units/week

7. Current smokers and those who have smoked within the last 6 months

8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months

9. Do not have suitable veins for multiple venipunctures

10. Clinically significant abnormal biochemistry, haematology or urinalysis

11. Positive urine drug screen at screening and admission for each period

12. Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results

13. History of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory, or gastrointestinal disease, or psychiatric disorder

14. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

15. Clinically significant allergy requiring treatment. Hayfever is allowed unless active

16. Donation or loss of greater than 400 mL of blood within the previous 3 months

17. Taking or have taken, any prescribed or over-the counter drugs or herbal remedies in the 14 days before IMP administrations. Exceptions may apply

18. Injection sites containing any skin discolouration, tattoo, scar tissue or other abnormalities that may impair injection site assessment

19. Any food or drink containing grapefruit or Seville oranges within 7 days prior to first dose of buprenorphine

20. Treatment with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) 3A4 and/or cytochrome 450 2C8 enzyme within 30 days prior to first dose of study drug

21. Clinically significant abnormal ECG, including QT interval corrected using Fridericia's formula of greater than 450msec in males and greater than 470 msec in females