Study of a Novel Subcutaneous Depot Formulation of Buprenorphine

NCT03715634 | Completed Phase 1

• 1 other identifier: INDV-6200-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (4)

• Assessment of PK of INDV-6200 (buprenorphine)

  The key parameter of the time of maximum concentration (Tmax) of buprenorphine will be evaluated.

  84 days

• Assessment of PK of INDV-6200 (buprenorphine)

  The key parameter of the maximum concentration (Cmax) of buprenorphine will be evaluated.

  84 days

• Assessment of PK of INDV-6200 (buprenorphine)

  The key parameter of the cumulative area under the curve (AUC) for each PK sample will be evaluated.

  84 days

• Assessment of PK of INDV-6200 (buprenorphine)

  The key parameter of the half life of buprenorphine will be evaluated.

  84 days

Secondary Outcomes (12)

• Assessment of PK of INDV-6200 (norbuprenorphine)

  84 days

• Assessment of PK INDV-6200 (norbuprenorphine)

  84 days

• Assessment of PK of INDV-6200 (norbuprenorphine)

  84 days

• Assessment of PK of INDV-6200 (norbuprenorphine)

  84 days

• Incidence of treatment emergence adverse events (TEAE) as assessed by changes in physical examination.

  Through day 84

Study Arms (2)

Depot buprenorphine (INDV-6200)

EXPERIMENTAL

Period 1 subjects will receive SL buprenorphine to confirm tolerance to product Period 2 subjects will receive depot buprenorphine

Drug: INDV-6200; Drug: SL Buprenorphine; Drug: Nalorex

Placebo

PLACEBO COMPARATOR

Period 1 subjects will receive SL buprenorphine to confirm tolerance to product Period 2 subjects will receive volume-matched placebo

Drug: Placebo; Drug: SL Buprenorphine; Drug: Nalorex

Interventions

INDV-6200 DRUG

Subjects will be randomized in a 3:1 ratio to receive either depot buprenorphine or volume-matched placebo

Depot buprenorphine (INDV-6200)

Placebo DRUG

Subjects will be randomized in a 3:1 ratio to receive either depot buprenorphine or volume-matched placebo

Placebo

SL Buprenorphine DRUG

All subjects will receive SL buprenorphine as non-investigational IMP to confirm tolerability

Also known as: Subutex

Depot buprenorphine (INDV-6200); Placebo

Nalorex DRUG

Both Periods will include series of nalorex administrations to antagonize potential opioid effects from buprenorphine

Depot buprenorphine (INDV-6200); Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or non-pregnant, non-lactating females
• Body mass index of 18.0-33.0 kg/m2 or, if outside the range, considered not clinically significant by the Investigator
• Willing and able to communicate and participate in the whole study
• Provide written informed consent prior to any study specific procedures
• Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment, ECG, and laboratory investigations
• Males and females must agree to use an adequate method of contraception
• Tolerated SL buprenorphine and nalorex during Period 1

You may not qualify if:

• Medical history of opioid-related adverse reactions
• History of clinically significant alcohol/drug abuse in the previous 5 years
• Received any investigational medicinal product within the previous 3 months
• Study site employees or immediate family members of study site or sponsor employee
• Previously enrolled in the study
• Regular alcohol consumption in males greater than 21 units/week and females greater than 14 units/week
• Current smokers and those who have smoked within the last 6 months
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months
• Do not have suitable veins for multiple venipunctures
• Clinically significant abnormal biochemistry, haematology or urinalysis
• Positive urine drug screen at screening and admission for each period
• Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results
• History of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory, or gastrointestinal disease, or psychiatric disorder
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Clinically significant allergy requiring treatment. Hayfever is allowed unless active

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine; Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone

Study Officials

• Nand Singh

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 23, 2018
• Study Start: September 20, 2017
• Primary Completion: June 7, 2018
• Study Completion: June 7, 2018
• Last Updated: March 4, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)