A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine

Kinnov Therapeutics

Status and phase

Completed

Phase 1

Conditions

Alcohol Use Disorder

Treatments

Drug: KT110

Drug: Prazosin + cyproheptadine

Study type

Interventional

Funder types

Other

Identifiers

NCT06147622

OP111821.KIN

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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