The Healthy Male Studies is a clinical trial experimenting with investigational medications for blood pressure and malaria. The phase one drugs are in early stage work and must be tested to observe how they are absorbed and metabolized in people. Independent studies have been conducted on both drugs.
VRG/NOCCR is welcoming volunteers for both studies. With April, May and June being the most intensive times to sign up, one group has already filled up, but VRG does have current openings and are accepting applicants through the summer.
“We thought there might be an interest for college students to participate in a research study and to learn about the process,” Jeff Gary, Director of Marketing for VRG/NOCCR said.
Gary explained that there are certain conditions that apply to each of the studies.
In order to participate in either study, volunteers must pass a pre-screening before being admitted. The pre-screening includes an echocardiogram, blood pressure check and blood and urine tests. Clinical coordinators want to make sure volunteers are healthy, have not taken any medications or indulged in illicit drugs, since it would interfere with the evaluations and present a risk to the health of the volunteer. Volunteers are not permitted to smoke.
“We want to have as healthy a person as possible,” said William Smith, physician for VRG clinical trials.
Smith is a nephrologist, cardiologist and intensivist with 35 years of experience with clinical trials. His colleague in the studies, Richard Gibson, is a psychiatrist, nephrologist and intensivist, and has a master's in tropical medicine.
Smith joked that with their experience, “both of us are a little bit over-trained.”
The malaria study involves a combination of medicines that is expected to reduce resistance to the drug for those who have contracted the disease. The drug is similar to current on-the-market ACE inhibitors. The only recorded side effect was an allergic reaction that happens in less than one percent of the people who received the medication.
“This is a drug that will hopefully protect the kidneys when people are exposed to certain kinds of x-ray contrasts, which can cause kidneys to fail,”- William Smith, physician for VRG
“This is a drug that will hopefully protect the kidneys when people are exposed to certain kinds of x-ray contrasts, which can cause kidneys to fail,” Smith said.
The blood pressure study explores a new derivative drug used for preventative medication. The blood pressure drug has seen occasional changes in liver enzymes but once participants ceased taking it, the enzymes were reported to return to normal and the side effect was felt to be insignificant.
“We never know in these early phase studies that they [the volunteers] are going to be 1000 percent safe, but with both of these drugs, they’re built to have a very low risk,” Smith reassured.
Common side effects with the drugs include a change in blood pressure, heart rate and occasional feelings of flushing, or warmth. Nausea is common but could be induced by anxiety from being in a study or related to the medication, Smith and his researchers are unsure which.
Between the two studies, 200 volunteers are needed. One study is open to males ages 18-55 and the other is open to males and females ages 18-45, but is not intended for women with reproductive potential and must have been surgically sterilized to be considered.
The studies require that volunteers be admitted as in-patient and must stay in the study unit. One study requires participants to stay for 6 days and 5 nights, while the other, slightly less intense, is 5 days and 4 nights. VRG/NOCCR also conduct outpatient studies that do not require overnight stay.
“We would love to have some folks come talk with us, where we could go into more detail about the specifics for that time period,” said Smith.
Smith encourages students that have an interest to contact recruiters by calling 865-305-DRUG (3784) to participate in a study. Students may call the VRG/NOCCR business line at 865-305-9100 or view the study volunteer section of their website.