Post by sam9009 on Apr 17, 2017 14:27:17 GMT -5
To Qualify, Participants Must Be:
• Men and women age 18-65
• Generally healthy & not currently taking any prescribed or over-the-counter medications (or must be willing to stop for appmately 28 days)
• Women must be at least 12 months post-menopausal or surgically sterile
• Non Smokers
At your first visit, called the Screening Visit, we will ask you questions and do some tests to see if you can be part of the study. Also, you will have a chance to ask any questions you may have to see if you want to be in the study.
If you take part in this study, you will have 3 more visits over about a 2-week period. You will only have to sleep over at the study center during the second visit, for 4 nights. The Overnight Visit may start as soon as the day after the Screening Visit, or as long as 4 weeks later. After the Overnight Visit, you will return to the study center 4 days later for a short Follow-Up Visit. You will then come back one week after that, for the End-of-Study Visit.
SAGE-718 is a liquid that you drink. At the Overnight Visit, you will either be given a dose of SAGE-718 or placebo, a liquid solution which looks and tastes just like the SAGE-718 but does not contain the active drug. Neither you nor the study staff will know if you are getting the SAGE-718 or placebo unless they need to find out to protect your safety. During the study, you will only be given 1 dose of either SAGE-718 or placebo.
You will take your dose of SAGE-718 or placebo on an empty stomach and will not eat any food from bedtime the night before until 4 hours after dosing the next morning. You may drink water up until 2 hours before dosing and then again, starting at 2 hours after dosing. As many as 9 different strengths of SAGE-718 may be used, starting with the weakest dose. The next, bigger dose will only be given if the weaker dose had no serious side effects. Whether you get SAGE-718 or placebo will be assigned by chance, like flipping a coin. Three out of every 4 subjects will get SAGE-718 (75% chance) while 1 out of every 4 will get the placebo (25% chance).
No matter which group you are in, or whether you get SAGE-718 or placebo, blood and other tests will be done before and after you take your dose. These tests will allow us to monitor your safety and measure how much of the drug is in your body at different times.
• Men and women age 18-65
• Generally healthy & not currently taking any prescribed or over-the-counter medications (or must be willing to stop for appmately 28 days)
• Women must be at least 12 months post-menopausal or surgically sterile
• Non Smokers
At your first visit, called the Screening Visit, we will ask you questions and do some tests to see if you can be part of the study. Also, you will have a chance to ask any questions you may have to see if you want to be in the study.
If you take part in this study, you will have 3 more visits over about a 2-week period. You will only have to sleep over at the study center during the second visit, for 4 nights. The Overnight Visit may start as soon as the day after the Screening Visit, or as long as 4 weeks later. After the Overnight Visit, you will return to the study center 4 days later for a short Follow-Up Visit. You will then come back one week after that, for the End-of-Study Visit.
SAGE-718 is a liquid that you drink. At the Overnight Visit, you will either be given a dose of SAGE-718 or placebo, a liquid solution which looks and tastes just like the SAGE-718 but does not contain the active drug. Neither you nor the study staff will know if you are getting the SAGE-718 or placebo unless they need to find out to protect your safety. During the study, you will only be given 1 dose of either SAGE-718 or placebo.
You will take your dose of SAGE-718 or placebo on an empty stomach and will not eat any food from bedtime the night before until 4 hours after dosing the next morning. You may drink water up until 2 hours before dosing and then again, starting at 2 hours after dosing. As many as 9 different strengths of SAGE-718 may be used, starting with the weakest dose. The next, bigger dose will only be given if the weaker dose had no serious side effects. Whether you get SAGE-718 or placebo will be assigned by chance, like flipping a coin. Three out of every 4 subjects will get SAGE-718 (75% chance) while 1 out of every 4 will get the placebo (25% chance).
No matter which group you are in, or whether you get SAGE-718 or placebo, blood and other tests will be done before and after you take your dose. These tests will allow us to monitor your safety and measure how much of the drug is in your body at different times.
