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Single Ascending Dose Study of RBP-6000

NCT03002961 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-12-26

No results posted yet for this study

Summary

A multi-center, open-label, single ascending dose study to enroll opioid dependent treatment-seeking subjects. Subjects to be enrolled into 3 cohorts receiving low, medium and high doses of depot buprenorphine. A fourth cohort will be enrolled to evaluate the PK of RBP-6000 after receiving suboxone tablets for 7 days.

Conditions

Interventions

DRUG

RBP-6000

single dose of RBP-6000, preceded by a pharmacokinetic (PK) sample followed by serial PK samples post-dose. Additionally subjects to remain in the clinic through Day 21 for safety assessments

DRUG

Suboxone

RBP-6000 injection after 7 days of SL Suboxone administration. Interventions as above with additional daily PK collections during Suboxone treatment prior to RBP-6000 administration

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-02-28
Completion
2013-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03002961 on ClinicalTrials.gov