CAM2038, PK, bioavailability and safety in healthy volunteers

• Research type

  Research Study

• Full title

  A Phase I, Randomized, Open-label, Active Controlled, Three-way Treatment Trial Assessing Pharmacokinetics, Bioavailability and Safety of Three Doses of CAM2038 q1w (Once-weekly) (Buprenorphine FluidCrystal® Injection Depot), Versus Active Comparators, Intravenous and Sublingual Buprenorphine in Healthy Volunteers under Naltrexone Blockage

• IRAS ID

  141172

• Contact name

  Muna Albayaty

• Contact email

  muna.albayaty@parexel.com;tshibuabua.kabasela@PAREXEL.com

• Sponsor organisation

  CAMURUS AB

• Eudract number

  2013-004004-19

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a phase I, randomized, open-label, active controlled, three-way treatment trial assessing pharmacokinetics, bioavailability, safety and tolerability of CAM2038 q1w (Buprenorphine FluidCrystal® injection depot) 8 mg, 16 mg and 32 mg versus active comparators, intravenous and sublingual buprenorphine under naltrexone blockage.

  CAM2038 is a ready-to-use, extended release product being developed by Camurus AB for once-weekly maintenance treatment of opioid dependency.

  Several buprenorphine products are presently registered for the treatment of opioid dependence and have been demonstrated to significantly reduce opioid-positive urines, i.e., to reduce illicit drug use, and increase retention of patients in treatment programs. Despite demonstrated efficacy, there are also issues with current products for opioid dependency treatments. These issues include abuse, misuse and diversion of medications, and accidental pediatric exposure.

  CAM2038 is being developed using FluidCrystal® (FC) injection depot technology. Injection of CAM2038 into subcutaneous tissue results in an immediate and spontaneous formation of controlled buprenorphine release providing long-acting effect. CAM2038 is designed for convenient and safe subcutaneous injection using a prefilled syringe with a needle safety device, with no need for mixing or temperature adjustment prior to administration.

  Healthy adult male or female volunteers ≥ 18 and ≤ 65 years of age will be included in this study conducted at an Early Phase Clinical Unit.

  The estimated duration of the trial for each participant is approximately 13 weeks, including a 4 week Screening period. The overall duration of the trial will be approximately 6 months.

  After having given informed consent, eligible participants will undergo study procedures, including physical examinations, electrocardiograms, vital sign measurements, O2 saturation by pulse oximetry, safety laboratory assessments (hematology, clinical chemistry, urinalysis, drugs-of-abuse screen, urine alcohol test, pregnancy tests [females], and serology).

  Safety will be evaluated: treatment emergent adverse events (TEAEs) including systemic tolerability, participant questionnaires, and by changes in vital signs measurements, ECGs, and O2 saturation by pulse oximetry.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  13/SC/0548

• Date of REC Opinion

  12 Dec 2013

• REC opinion

  Further Information Favourable Opinion