Study Details

Healthy Adults, Age 18-65

Study Number

8446-278 A1

Group

Part A Group 1

Gender

both

Age

18-65

Location

Daytona Beach, Florida

Compensation

$2,754

Study Dates

Nov. 11 - 25, 2020

Additional Information

The investigational drug in this research study is being developed for the potential treatment of nonalcoholic steatohepatitis (NASH), an advanced form of non-alcoholic fatty liver disease. This is the first time that this study drug is being given to humans.

Part A

The purpose of Part A is to evaluate safety, tolerability, how much of the study drug gets into the bloodstream and how long the body takes to get rid of it.  You will receive a single, oral dose of the study drug or placebo in the form of capsules.

• Healthy Adults, Age 18-65

• Women must be surgically sterile or postmenopausal

• BMI (body mass index) 18.5-40

• Available for 1 stay of 7 overnights & 1 follow up visit

• Compensation up to $2,754 may be provided for time and participation.

Details

Screening: Oct 15, 16, 19, 20, 21, 22, 23, 26, 27 & 28

Check-in: Nov 11
Check-out: Nov 18

Follow up Visit: Nov 25

Study Number

8446-278 A1

Group

Part A Group 1

Gender

both

Age

18-65

Location

Daytona Beach, Florida

Compensation

$2,754

Study Dates

Nov. 11 - 25, 2020

Additional Information

The investigational drug in this research study is being developed for the potential treatment of nonalcoholic steatohepatitis (NASH), an advanced form of non-alcoholic fatty liver disease. This is the first time that this study drug is being given to humans.

Part A

The purpose of Part A is to evaluate safety, tolerability, how much of the study drug gets into the bloodstream and how long the body takes to get rid of it.  You will receive a single, oral dose of the study drug or placebo in the form of capsules.

• Healthy Adults, Age 18-65

• Women must be surgically sterile or postmenopausal

• BMI (body mass index) 18.5-40

• Available for 1 stay of 7 overnights & 1 follow up visit

• Compensation up to $2,754 may be provided for time and participation.

Details

Screening: Oct 15, 16, 19, 20, 21, 22, 23, 26, 27 & 28

Check-in: Nov 11
Check-out: Nov 18

Follow up Visit: Nov 25

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