None listed
Conditions
Brief summary
Emestedastat was created to decrease the production of cortisol by the brain. This drug has been previously tested in nearly 400 people, including healthy adults and people with Alzheimer’s Disease and depression. The research project will test what the body does to emestedastat, such as how quickly it enters, moves through, and leaves the body. In particular, the research project will test if eating food has any effect on what happens to emestedastat in the body. If this and other clinical research projects are successful, the treatment being studied may be approved to treat people with Alzheimer’s Disease or depression in the future.
Interventions
emestedastat 10 mg oral tablet, 2 single doses, with a washout period of one week between treatments. Doses will be taken in either the fasted or fed state, both states are under assessment.
Doses will be taken under supervision and will be checked by a second member of staff. A hand and mouth check will be conducted after each participant has been dosed.
The fed state involves consumption of a high fat and high calorie meal during a 30-minute period that commences 45 minutes prior to dosing. It
emestedastat 10 mg oral tablet, 2 single doses, with a washout period of one week between treatments. Doses will be taken in either the fasted or fed state, both states are under assessment. Doses will be taken under supervision and will be checked by a second member of staff. A hand and mouth check will be conducted after each participant has been dosed. The fed state involves consumption of a high fat and high calorie meal during a 30-minute period that commences 45 minutes prior to dosing. It should derive approximately 150, 250, and 500 to 600 calories from protein, carbohydrate, and fat, respectively, as defined in regulatory guidance. The fasted state involves a 10-hour overnight fast.
Sponsors
Actinogen Medical Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Participants in good general health BMI between 18 and 32, inclusive Non-smoker, able to abstain from caffeine/hot beverage intake prior to dosing No relevant dietary restrictions and able to consume the non-vegetarian, high-fat meal provided
Exclusion criteria
Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality Abnormalities in vital signs, ECG abnormalities Use of any prescription drugs, over the counter medication, herbal remedies, supplements or vitamins, apart from simple analgesia Unwilling to refrain from strenuous exercise during the trial Not breastfeeding, lactating or planning pregnancy History of drug or alcohol abuse
Outcome results
None listed