Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label study in treatment seeking opioid-dependent subjects for safety, tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of subcutaneous injections of depot buprenorphine after induction and stabilization of treatment seeking subjects onto Subutex.

Subjects were planned to receive 4 subcutaneous (SC) injections of RBP-6000 separated by 28 days (Cohorts 1-5) or 6 SC injections of RBP-6000 separated by 28 days (Cohort 6) after a 13-day induction and dose stabilisation period on SUBUTEX Sublingual (SL) tablet at dose levels of 8-24 mg.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indivior Inc.
• Treatments: Analgesics, Opioid; Buprenorphine

Criteria

Inclusion Criteria:

• Male and female subjects

• Agree not to take any buprenorphine products other than those administered for the current study throughout participation in the study

• Body mass index (BMI) of >18.0 to < 33.0 kg/m

Exclusion Criteria:

• Participants with a current diagnosis requiring chronic opioid treatment

• Participants with a history of risk factors of Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or an ECG demonstrating a Fridericia's corrected QT interval (QTcF) >450 msec in males and QTcF > 470 in females at screening

• Abuse of buprenorphine or use of buprenorphine within 14 days of informed consent