PF-05190457

Background:
- Hormones are naturally occurring chemicals in your body. Ghrelin is a hormone that is mainly produced by the stomach and stimulates appetite. Some studies suggest it may stimulate alcohol craving and use. Drugs have been developed that block ghrelin. Researchers want to know if people can tolerate a particular drug that blocks ghrelin. It will be given at two dose levels, combined with alcohol.
Objective:
- To determine if a drug that may decrease alcohol consumption when given along with alcohol is safe and tolerable.
Eligibility:
* Healthy adults 21-65 years old who have 14 (women) to 21 (men) drinks a week.
* No one of childbearing potential can participate.
Design:
* Participants will have 3 inpatient clinic visits; each will last 4 days.
* They will have physical exam and blood and urine tests.
* They will have breath tests for alcohol and smoking.
* They will answer health and mood questions.
* Researchers will measure their reaction to smelling alcohol and tasting a sweet drink.
* They will eat only the food provided by the clinic. They will keep a food diary 1 day before each stay.
* They will be randomly assigned to take the study drug or placebo 5 times each stay.
* On Day 3, they will drink alcohol after taking the drug. They will give many blood samples that day through a tube inserted in their skin.
* Smokers can take smoke breaks. Once, they will smoke a cigarette through a device.
* One week after the last stay, participants will have a follow-up visit to answer questions.

The purpose of the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers.