Status:
COMPLETED
A Safety and Effectiveness Pilot Study of PRF-108 and PRF-110 in Healthy Volunteers
Lead Sponsor:
PainReform LTD
Conditions:
Pain
Eligibility:
MALE
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers. PRF-108 and PRF-110 are ...
Detailed Description
This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers. PRF-108 and PRF-110 are ...
Eligibility Criteria
Inclusion
- Male subjects between 18-60 years of age;
- Subjects are within ±10% of ideal body weight/height (based on frame size) as given by the Metropolitan Life Insurance Tables;
- Subjects are ASA Category I and in normal physical health as judged by physical and laboratory examinations and have a negative urine based screen for drugs of abuse;
- Subjects must agree to refrain from ingesting any analgesic medication for 3 days or 5 half-lives of the drug prior to and during the study period and alcohol for 1 day prior to and during the study period;
- Subjects can tolerate a 0.5mL injection of saline in the lower back area.
- The subject is capable of reading, comprehending, and signing the informed consent form.
Exclusion
- Subjects with a history of any significant hepatic, renal, endocrine, cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders, including glaucoma, diabetes, emphysema, and chronic bronchitis;
- Subjects with a history of any type of cancer;
- Subjects with conditions that affect the absorption, metabolism, or passage of drugs out of the body, (e.g., sprue, celiac disease, Crohn's disease, colitis, or liver, kidney, or thyroid conditions);
- Subjects with any history of alcohol or substance abuse (including a positive drug screen test);
- Subjects that currently have or have a history of hypertension;
- Subjects with a known hypersensitivity to any local anesthetic drug;
- Subjects with a history of benign prostatic hyperplasia or difficulty in urination;
- Subjects with a hematocrit level below the normal range on the screening laboratory examination;
- Subjects with any clinically significant abnormal lab result (as judged by the Principal Investigator);
- An abnormal ECG at screening including PR\>200 ms, QRS\>110 ms, QTcF\<380 or \>400 ms, lead II T wave abnormalities. Non-specific T wave abnormalities in leads other than lead II are permissible if not accompanied by any other morphological abnormalities.
- Subjects with any condition or history felt by the Investigator to place the subject at increased risk;
- Subjects who have smoked or chewed tobacco-containing substances within 6 months prior to the start of the study;
- Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol;
- Subjects who have used an investigational drug within 30 days prior to entering the study;
- Subjects who have donated blood within 3 months prior to the start of the study (including blood donation related to the surgical procedure);
- Subjects who have previously participated in the trial;
- Subjects who are members of the study site staff directly involved with the study or a relative of the Sponsor or other personnel involved with the study.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00883194
Start Date
October 1 2010
End Date
April 1 2011
Last Update
November 16 2020
Active Locations (1)
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1
Hadassah University Hospital
Jerusalem, Israel