31.Dec.2014

OCT was granted a phase I trial of new formulation of narcotic analgesics drug

OCT is happy to announce that we were granted another phase I trial of a narcotic analgesics drug by one of the fast-growing Russian pharmaceutical companies.

This single-group single-dose phase I clinical trial of pharmacokinetics and safety of the analgesics drug which is rectal suppositories is planned to be conducted in healthy volunteers. 

The main goal of the study is to examine pharmacokinetic parameters of the investigational product after single dose administration in comparison to the intramuscular administration of the drug in the dosage form of solution. The protocol of the current clinical study does not anticipate administration of the comparator drug. Pharmacokinetic parameters of the investigational product will be compared to the literature data.

The second goal of the study is to evaluate the safety parameters of the drug after single dose administration.

In order to recruit 16 healthy volunteers that meet all the inclusion criteria and mismatch the non-inclusion criteria for the current study, 20 volunteers will be screened. Volunteers’ enrollment will be conducted by the investigators who have experience of drastic narcotic analgesics drugs administration. 

Since the investigational drug is a semi-synthetic opioid, that work by binding to opioid receptors, which are present in the central and peripheral nervous system and can cause numbness and induce a state of unconsciousness, the phase I unit (the medical center where the clinical trials in healthy volunteers are conducted) must be well-equipped with everything needed for the therapy of opioid overdose symptoms’, including intubation instruments and equipment for artificial respiration maintenance.

Since 2005 when OCT entered the market of clinical trials, we have conducted about 20 studies in healthy volunteers. Such experience helped our clinical team choose the phase I unit and the highly-qualified principal investigator that meet all the requirements for the current study.