Status:
COMPLETED
A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine
Lead Sponsor:
Kinnov Therapeutics
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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-o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06147622
Start Date
April 23 2024
End Date
December 31 2024
Last Update
March 13 2025
Active Locations (1)
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1
Eurofins Optimed
Gières, France, 38610