drugset / Trial / NCT03810495
The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers
Phase 1
Completed
20 enrolled
Go Medical Industries Pty Ltd
Clinilabs, Inc. · collabColumbia University · collabNational Institute on Drug Abuse (NIDA) · collabNew York State Psychiatric Institute · collab
NaSingle-groupOpen-labelBasic science
Summary
This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner. No randomization will occur. It is hypothesized that the OLANI will provide sustained therapeutic doses of naltrexone (NTX) for periods up to 6 months via a single subcutaneous application of 2 OLANIs.
Timeline
- Start
- 2019-04-11
- Primary completion
- 2021-03-18
- Completion
- 2021-03-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 1.8 g | Subcutaneous |