Alcohol Use Disorder
Conditions
Brief summary
The study is an open-label, randomized,2-period, single dose, crossover study in 8 healthy male/female volunteers. Subjects will be randomized to the following sequences: (A) Period 1: KT110 - wash-out period - Period 2: Alpress and Periactin marketed tablets ; Or (B) Period 1: Alpress and Periactin marketed tablets - wash-out period - Period 2: KT110
Interventions
DRUGPrazosin + cyproheptadine
Subjects will receive prazosin + cyproheptadine on day 1 of period 1 or on day 1 of period 2 depending on randomization.
DRUGKT110
Subjects will receive KT110 on day 1 of period 1 or on day 1 of period 2 depending on randomization.
Sponsors
Kinnov Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
open-label, randomized, 2-period, single dose, crossover study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male/female subject * Females of childbearing potential and male participant must agree to use an adequate and highly effective method of contraception * Negative serum pregnancy test at screening for woman of childbearing potential only * Non-smoker subject or smoker of not more than 5 cigarettes a day * Body Mass Index (BMI) between 18.5 and 30 kg/m2 inclusive, at screening
Exclusion criteria
* Any contraindication to Prazosin or Cyproheptadine treatments; * Frequent headaches and / or migraine, recurrent nausea and / or vomiting; * Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease equal to or greater than 20 mmHg in systolic blood pressure (SBP) and a decrease equal to or greater than 10 mmHg in diastolic blood pressure (DBP) within two minutes of changing from supine to standing position; * Blood donation (including as part of a clinical trial) in the 2 months before administration * Any drug intake (except paracetamol or contraception) during the month prior to the first administration; * History or presence of drug or alcohol abuse (alcohol consumption \> 40 grams / day) * Excessive consumption of beverages with xanthine bases (\> 4 cups or glasses / day); * Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests * Positive results of screening for drugs of abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC (area under the curve) 0-t | Day 4 | Area under the curve from time 0 to the last measurable concentration at time t |
| AUC 0-inf | Day 4 | Area under the curve from time 0 extrapolated to infinity (only for Cyproheptadine) |
| Cmax | Day 4 | Maximum observed concentration |
| Tmax | Day 4 | Time of maximum observed concentration |
| T1/2 | Day 4 | Apparent elimination half-life |
| K el | Day 4 | Apparent Elimination rate constant |
Countries
France
Outcome results
None listed