Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder

Recruiting at 3 trial locations

Overseen By Robert Dobbins

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Indivior Inc.

Must be taking: Suboxone

Must not be taking: CYP3A4 inhibitors/inducers

Disqualifiers: Cardiac illness, Hepatic disease, HIV, others

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the safety of a new drug, INDV-2000, in healthy volunteers and people with opioid use disorder. The goal is to see if the drug is safe when taken multiple times, both alone and with SUBOXONE.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, for healthy volunteers in Parts I and II, you should not have taken any prescribed or over-the-counter drugs (except certain exceptions) in the 14 days before the trial. For Part III, those seeking treatment for opioid use disorder should not have received medication-assisted treatment like methadone or buprenorphine in the 30 days before the trial.

Research Team

Martin Kankam

Principal Investigator

altasciences

Ellen Remenchik

Principal Investigator

Worldwide Clinical Trails

Eligibility Criteria

Inclusion Criteria

Able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, be able to comply with protocol requirements, rules and regulations of study site, and be likely to complete all the study interventions.

Female subjects of child-bearing potential who are sexually active with males must use, with their partner, a condom plus an approved method of effective contraception from the time of screening until 30 days after the last dose of Investigational Medicinal Product (IMP). The impact of IMP on the efficacy of hormonal contraceptives is unknown. Male subjects who are sexually active with female partners of child-bearing potential must use, with their partner, a condom plus an approved method of effective contraception from the time of screening until 90 days after the last dose of IMP and agree to not donate sperm over this time period. Effective methods of contraception are: Combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal; Progestogen-only hormonal contraception: oral, injectable/implantable, or intrauterine hormone-releasing system (IUD); Implantable intrauterine device (IUS); Surgical sterilization (for example, vasectomy or bilateral tubal ligation); Male condom with spermicidal gel/foam or with female cap or diaphragm (double barrier); abstinence from heterosexual intercourse as a conscious choice and established pattern of lifestyle.

Healthy male or female. Between 18 and 55 years of age inclusive. Body mass index (BMI) within 18.0 to 32.0 kg/m^2, inclusive (minimum weight of at least 50.0 kg at Screening).

Exclusion Criteria

Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder as judged by an Investigator.

Have clinically significant abnormal biochemistry, hematology or urinalysis results as judged by an Investigator or medically responsible physician.

Have disorders that may interfere with drug absorption, distribution, metabolism and excretion (ADME) processes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part I

Double-blind, placebo-controlled, randomized, multiple ascending dose study for 7 days of dosing with INDV-2000 in healthy volunteers

1 week

Daily visits for dosing

Treatment Part II

Double-blind, placebo-controlled, randomized, multiple ascending dose study for 28 days of dosing with INDV-2000 in healthy volunteers

4 weeks

Daily visits for dosing

Treatment Part III

Open-label study in OUD treatment seeking individuals with a run-in period of SUBOXONE SL film for 6 days, followed by combination treatment with INDV-2000 and SUBOXONE for 7 days, and INDV-2000 alone for 4 days

17 days

Daily visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• INDV-2000
• Placebo
• SUBOXONE® sublingual film

Participant Groups

Group I: Part III INDV-2000 400 mg BID + SUBOXONE SL Film Experimental Treatment 2 Interventions

Participants with opioid use disorder will receive SUBOXONE sublingual (SL) film for 6 days during the run-in period. Participants will then receive SUBOXONE SL film alone for 2 days, then SUBOXONE SL film and INDV-2000 for 7 days followed by INDV-2000 dosing alone for 4 days.

Group II: Part II Cohort 2 INDV-2000 400 mg BID Experimental Treatment 1 Intervention

Healthy volunteers will receive INDV-2000 400 mg twice daily for 28 days.

Group III: Part II Cohort 1 INDV-2000 200 mg BID Experimental Treatment 1 Intervention

Healthy volunteers will receive INDV-2000 200 mg twice daily for 28 days.

Group IV: Part I Cohort 2 INDV-2000 100 mg BID Experimental Treatment 1 Intervention

Healthy volunteers will receive INDV-2000 100 mg twice daily for 7 days.

Group V: Part I Cohort 1 INDV-2000 100 mg QD Experimental Treatment 1 Intervention

Healthy volunteers will receive INDV-2000 100 mg once daily for 7 days.

Group VI: Part I Cohort 1 Placebo Placebo Group 1 Intervention

Healthy volunteers will receive placebo once daily for 7 days.

Group VII: Part I Cohort 2 Placebo Placebo Group 1 Intervention

Healthy volunteers will receive placebo twice daily for 7 days.

Group VIII: Part II Cohort 1 Placebo Placebo Group 1 Intervention

Healthy volunteers will receive placebo twice daily for 28 days.

Group IX: Part II Cohort 2 Placebo Placebo Group 1 Intervention

Healthy volunteers will receive placebo twice daily for 28 days.

Who Is Running the Clinical Trial?

Indivior Inc.

Lead Sponsor

Trials

56

Recruited

11,400+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+