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Also known as C4X_3256
INDV-2000 · 3 trials · 4 indications
The treatment failure is defined as meeting either one of the two criteria. 1. Urine Drug Screen (UDS, dipstick) positive for opioids, or fentanyl on 4 consecutive assessments while participants on the Investigational Medicinal Product (IMP) (INDV-2000 or placebo) alone (after Day 8 visit). 2. Discontinued the IMP (INDV-2000 or placebo) prematurely.
An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors. A serious AE is any event that met any of the following criteria: * Death * Life-threatening * In-patient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome. A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening.
| Arm | Type | Description |
|---|---|---|
| 100 mg INDV-2000 QD dosed by two 50 mg extended-release tablets | EXPERIMENTAL | - |
| 200 mg INDV-2000 QD dosed by two 100 mg extended-release tablets | EXPERIMENTAL | - |
| 400 mg INDV-2000 QD dosed by two 200 mg extended-release tablets | EXPERIMENTAL | - |
| Placebo dose | PLACEBO_COMPARATOR | - |
| Part I Cohort 1 INDV-2000 100 mg QD | EXPERIMENTAL | Healthy volunteers will receive INDV-2000 100 mg once daily for 7 days. |
| Part I Cohort 1 Placebo | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo once daily for 7 days. |
| Part I Cohort 2 INDV-2000 100 mg BID | EXPERIMENTAL | Healthy volunteers will receive INDV-2000 100 mg twice daily for 7 days. |
| Part I Cohort 2 Placebo | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo twice daily for 7 days. |
| Part II Cohort 1 INDV-2000 200 mg BID | EXPERIMENTAL | Healthy volunteers will receive INDV-2000 200 mg twice daily for 28 days. |
| Part II Cohort 1 Placebo | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo twice daily for 28 days. |
| Part II Cohort 2 INDV-2000 400 mg BID | EXPERIMENTAL | Healthy volunteers will receive INDV-2000 400 mg twice daily for 28 days. |
| Part II Cohort 2 Placebo | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo twice daily for 28 days. |
| Part III INDV-2000 400 mg BID + SUBOXONE SL Film | EXPERIMENTAL | 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. |
| Part I: INDV-2000 | EXPERIMENTAL | Participants will receive a single dose of INDV-2000. The starting dose is 1 mg with dose escalation dependent upon observed clinical safety, tolerability and pharmacokinetics. |
| Part I: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of matching placebo. |
| Part II: INDV-2000 Fasted/Fed | EXPERIMENTAL | Participants will receive a single dose of INDV-2000 orally on Day 1 under fasted conditions and a single dose of INDV-2000 after a high-fat breakfast on Day 8. Dose to be determined based on a well-tolerated dose studied in Part I. |
| Name | Type | Description |
|---|---|---|
| INDV-2000 | DRUG | INDV-2000 is a highly potent and selective OX1R antagonist that is being developed as a therapy for the treatment of OUD. |
| Placebo | OTHER | This is a randomized, double-blind, placebo-controlled study. |
| SUBOXONE® sublingual film | DRUG | Administered either under the tongue (sublingual) or between the gum and cheek (buccal) |
Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant must be 18 or the legal age of consent in the jurisdiction in which the study is taking place to 65 years of age inclusive, at the time of signing the informed ...
INDV-2000 is an investigational small molecule being developed for the treatment of opioid dependence and opioid use disorder. It is being studied in adults aged 18 years and older, including both healthy volunteers and treatment-seeking individuals with opioid use disorder.
INDV-2000 targets the OX1 receptor, also known as the orexin-1 receptor. It is a small molecule directed at this receptor as part of its development for opioid dependence and opioid use disorder.
INDV-2000 is being developed by Indivior Pharmaceuticals, Inc., which trades under the ticker INDV. The company is advancing the compound for opioid dependence and opioid use disorder.
INDV-2000 is in Phase 1 development, with completed Phase 1 trials and a completed Phase 2 proof-of-concept and dose-ranging study. It is an investigational drug and has not been approved by the FDA.
INDV-2000 has been studied in three completed trials: NCT04413552, a first-in-human Phase 1 study; NCT04976855, a Phase 1 repeated-dose study in healthy volunteers and treatment-seeking individuals with opioid use disorder; and NCT06384157, a Phase 2 proof-of-concept and dose-ranging study in moderate to severe opioid use disorder.
Across the completed clinical trials, 437 participants have been enrolled in studies of INDV-2000. The trials include randomized, double-blind, placebo-controlled designs, with enrollment spanning healthy volunteers and individuals with opioid use disorder.