PK, Bioavailability & Safety of CAM2038 q1w & q4w in healthies
Research type
Research Study
Full title
A Phase I, Randomized, Open-label, Active Controlled, Three-way Treatment Trial Assessing Pharmacokinetics, Bioavailability and Safety of Two Single Doses of CAM2038 (Buprenorphine FluidCrystal® Injection Depot) q4w (Once Monthly) and Four Repeat Doses of CAM2038 q1w (Once Weekly) Versus Active Comparators, Intravenous and Sublingual Buprenorphine in Healthy Volunteers under Naltrexone Blockage
IRAS ID
150293
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Camurus AB
Eudract number
2014-000498-38
ISRCTN Number
n/a
Research summary
The Sponsor is developing the study drugs for treating opioid dependency.
Opioid dependency is the addiction to opioids. Opioids are effective painkillers. They can also create feelings of intense pleasure or euphoria. People who misuse or abuse opioids can easily become addicted to them.
The new medicines tested in this study are two different strengths of a compound called CAM2038 (Buprenorphine FluidCrystal® [FC] injection depot). The two strengths of CAM2038 q4w (the meaning of q4w is once monthly injection) are intended to be injected once a month, while the third strength, CAM2038 q1w (the meaning of q1w is once weekly injection) is intended to be injected once a week.
This study will compare the study drugs to similar products already on the market, namely Temgesic® and Subutex®. Temgesic® and Subutex® contain the same active ingredient (Buprenorphine) as the study drugs.
The main purpose of the study is to see how safe the study drug is and to investigate how the study drug is taken up.
This study will recruit healthy, males and females between the ages of 18 and 65 years (inclusive). A total of 57 participants will take part in the study.
Vital signs, safety ECG measurements, O2 Saturation measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Plasma samples for pharmacokinetic analysis will be collected.
REC name
North East - York Research Ethics Committee
REC reference
14/NE/0083
Date of REC Opinion
3 Apr 2014
REC opinion
Further Information Favourable Opinion