# iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers

> **NCT07064564** · PHASE1 · NOT_YET_RECRUITING · sponsor: **Akyso Therapeutics, LLC** · enrollment: 33 (estimated)

## Conditions studied

- Opioid Use Disorder

## Interventions

- **DRUG:** Naltrexone implant, 14.4 grams
- **DRUG:** Naltrexone implant, 9.6 grams
- **DRUG:** Extended-release naltrexone injection, 380 mg

## Key facts

- **NCT ID:** NCT07064564
- **Lead sponsor:** Akyso Therapeutics, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-04-01
- **Primary completion:** 2027-06-01
- **Final completion:** 2029-03-31
- **Target enrollment:** 33 (ESTIMATED)
- **Last updated:** 2026-02-05

## Collaborators

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## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07064564

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07064564, "iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT07064564. Licensed CC0.

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