This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). The current study will evaluate the pharmacokinetics (PK), safety, and tolerability of INDV-6001 following multiple doses in participants with OUD to select optimum dosing regimens for future studies. Prior to receiving INDV-6001, participants will be stabilised on 12-16 mg of transmucosal (TM) BUP (SUBOXONE®) or will transition from a 100-mg monthly maintenance dose of SC extended-release BUP (SUBLOCADE®). This study will also evaluate the use of alternative injection sites (thigh, back of upper arm), which may be desirable in this patient population for the anticipated extended durations of treatment.
Moderate to Severe Opioid Use Disorder
This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). The current study will evaluate the pharmacokinetics (PK), safety, and tolerability of INDV-6001 following multiple doses in participants with OUD to select optimum dosing regimens for future studies. Prior to receiving INDV-6001, participants will be stabilised on 12-16 mg of transmucosal (TM) BUP (SUBOXONE®) or will transition from a 100-mg monthly maintenance dose of SC extended-release BUP (SUBLOCADE®). This study will also evaluate the use of alternative injection sites (thigh, back of upper arm), which may be desirable in this patient population for the anticipated extended durations of treatment.
INDV-6001 Multiple-Dose Pharmacokinetic Study
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Artemis Institute for Clinical Research, San Diego, California, United States, 92103
Innovative Clinical Research, Inc., Miami Lakes, Florida, United States, 33016
Chicago Clinical Research Institute Inc., Chicago, Illinois, United States, 60607
Precise Research Centers, Flowood, Mississippi, United States, 39232
Hassman Research Institute (Cenexel HRI - Marlton), Marlton, New Jersey, United States, 08053
Richmond Behavioral Associates, Staten Island, New York, United States, 10314
Midwest Clinical Research, Dayton, Ohio, United States, 45417
Insite Clinical Research, LLC, Desoto, Texas, United States, 75115
Memorial Hermann Village, Houston, Texas, United States, 77043
Pillar Clinical Research, Richardson, Texas, United States, 75080
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to 65 Years
ALL
No
Indivior Inc.,
2025-12