INDV-6001 Multiple-Dose Pharmacokinetic Study
Public ClinicalTrials.gov record NCT06576843. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Multicentre Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Repeated Doses of INDV-6001 in Adults With Moderate to Severe Opioid Use Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06576843
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 123 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 17, 2024 (Actual)
- Primary completion
- Jan 21, 2026 (Actual)
- Completion
- Jan 21, 2026 (Actual)
- Last update posted
- Mar 16, 2026
2024 – 2026
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Innovative Clinical Research, Inc. | Miami Lakes | Florida | 33016 | — |
| Chicago Clinical Research Institute Inc. | Chicago | Illinois | 60607 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| Hassman Research Institute (Cenexel HRI - Marlton) | Marlton | New Jersey | 08053 | — |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | — |
| Midwest Clinical Research | Dayton | Ohio | 45417 | — |
| Insite Clinical Research, LLC | DeSoto | Texas | 75115 | — |
| Memorial Hermann Village | Houston | Texas | 77043 | — |
| Pillar Clinical Research | Richardson | Texas | 75080 | — |
| Progressive Clinical Research | Bountiful | Utah | 84010 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06576843, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 16, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06576843 live on ClinicalTrials.gov.