a single dose pharmacokinetic Bioavailability in CBD
“A Single Dose Pharmacokinetic Study to Determine Bioavailability of Non encapsulated and Nanoencapsulated Cannabidiol (CBD) in Healthy Subjects” was conducted in Jamaica, West Indies, June 2018.
The study had a required number of sixty (60) healthy volunteers; one hundred and five (105) volunteers were screened of which seventy-one (71) were eligible. A total of thirty-four subjects screen failed. The main reasons included: exclusionary ECG results (14), exclusionary lab results (10) and positive drug test at screening (1). Other reported reasons for screening failing were: overweight (2) and (7) patients were undetermined. Screen failed subjects were contacted and referred for further evaluation if it
was necessary.
Selection for participation was based on the availability of the qualifying volunteer pool. Sixty (60) subjects were therefore enrolled into the study.
The adverse events were minor. One adverse event (scorching feeling under tongue/tingling sensation under tongue) was reported by the Principal Investigator as “related” to the investigation product (IP).
Preliminary graph results for the oral liquid administration shows absorption peaks at 60 minutes for the nano-encapsulated group and 120 minutes in the non- encapsulated CBD group.
The summary data shows higher bioavailability in the nano-encapsulated group compared to the non-encapsulated group.
Adverse events included bruising/soreness at site of needle stick, tenderness at site of catheter placement and were not related to the Investigational Product. There was an additional adverse event described as scorching feeling under tongue/tingling sensation under tongue.
The adverse events were minor. One adverse event (scorching feeling under tongue/tingling sensation under tongue) was reported by the Principal Investigator as “related” to the investigation product (IP).
All the adverse events were resolved by day two (2) of the study or by the 10-day study follow-up.
Side effects :
There were reports of restful sleep and resolution of minor chronic pain.
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CARIBBEAN
CLINICAL
RESEARCH
ASSOCIATES, LTD
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Sustainability of a Small Clinical Research Organization
In an Emerging Region: A Caribbean Perspective
In 2004 feasibility studies were conducted to explore the viability of conducting traditional clinical research trials in the Caribbean region. Clinical trials were being conducted in far reaches of Africa and India. Why would the Caribbean not be able to fully participate in the major pharmaceutical drug development industry as a full earning partner?
With many well-known international thought leaders emerging from first world academic centers, equipped hospitals and health care facilities in the region, the region is poised to be front runners in the industry. It was identified that there was research being conducted, mostly in academia. The UWI-Mona campus, Tropical Medical Research Institute (TMRI) under the leadership and faculty of Drs. Terrence Forrester, Michael Boyne and other associates were conducting research and growing a General Clinical Research Center (GCRC) unit on the campus of the University studying nutrition, sickle cell and occasionally an industry sponsored project.
Dr. Gordon-Strahan former director of the Mona Office for Research and Innovation in the early days trudged the ponds and airways to support the initial concept by being a presenter at the ACRP 2005 Annual Conference –San Diego, CA She provided supporting data from not only Jamaica and large island nations like Trinidad and Tobago but regional information which is reported into agencies like local Ministries of Health, Pan-American Health Organization and the World Health Organization. At that time, she was the Director of Epidemiological Research and Data Analysis at the Jamaica Ministry of Health. Dr. Gordon Strahan has joined the ranks for the now Caribbean Institute for Health Research previously known as the TMRI.
There was industry support from a well-known and recognized Phase 1 group and from Sponsors like Novartis to explore pediatric clinical trials, and other industry leaders. The outcome of the feasibility study was affirmative; conducting clinical research trials in the Caribbean is a viable concept.
As life defines itself and circumstances define decisions, the concept although viable needed sustainability factors.
In 2009 CCRA was able to further explore Caribbean locations and collaborations with other CROs including a small research group located in Trinidad and Tobago and research resources in Dominica, Grenada and St. Vincent. As the list of advisors grows, so does the reach into the Caribbean region.
“A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects with Tinea Pedis” was completed in St. Kitts and Nevis in 2010. Three sites, three Principal Investigators- with local doctors including Dr. Glenville Liburd led teams; the teams were developed and trained; ethical approval secured, subjects recruited, screened and enrolled, study samples transported to central lab in the US through international courier.
The seventy-eight (78) subject phase II project timeframe from initial considerations including Site Selection Visit through study implementation and Close Out Visit was less than < 18 months.
In 2017, CCRA was invited to Jamaica to monitor a phase III project. That opportunity gave way to potential sustainability whereas CCRA revitalized its efforts. As Jamaica was positioned to pioneer the legalization and de-criminalization of cannabis in the region; CCRA again found the viability of conducting clinical trials in the Caribbean region but now expanding into the nutraceutical space with cannabis and cannabinoid therapy.
In 2018 CCRA was awarded the project A Single Dose Pharmacokinetic Study to Determine Bioavailability of Non-Encapsulated and Nano encapsulated Cannabidiol (CBD) in Healthy Subjects. That project was a phase I project. The study location was secured, staff identified and trained, and study ancillary vendors identified and secured. The team was led by Dr. Lorenzo Gordon and supported by company advisors including Dr. Shelly McFarlane.
Sixty (60) healthy volunteers were recruited, screened and completed the study. The total study time from initial consideration including SSV through study implementation and Close Out Visit was less than 15 months.
Additional data continued to shape CCRA and more closely define what it would take to obtain ongoing sustainability. We learned that the length of time to get a study up and running mirrored our Latin American colleagues in Mexico and Columbia, hence the exploration of collaborations with global CROs. CROS like Parexel and MedPace which have an international presence either with or without a Latin American presence; or IQVIA or PRA. Opportunities are available and open for discussion.
Activities utilized to create sustainability:
To acquire sustainability, one must identify a source of ongoing projects.
Sustainability efforts have included cure mining, network and registering PIs on Sponsor websites. The next effort will be to create a collaboration with the top 10 CROs in the US. That effort was initiated by identifying CROs that met certain criteria that would be interested in developing a region or expanding their regional capabilities. The therapeutic areas include but not limited to: Cardiology, Woman’s Health, Oncology, Neurology, Gastroenterology, Hepatology including dialysis.
The creation of a strong clinical research/ drug development human resource pool based in the Caribbean that will aid these CROs to explore resources for virtual work responsibilities like CTA, eTMF, and other support areas in the industry.
Many of the CROs have company structured by either region or therapeutic areas.
The larger global companies have the luxury of having team members on the same project working in all parts of the world simultaneously. Let’s get the Caribbean basin doing more in Sponsor initiated clinical trials.
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