A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine

NCT ID: NCT06147622

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-23
• Study Completion Date: 2024-12-31

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

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

KT110

Subjects will be randomized to receive KT110 on period 1 or period 2

Group Type: EXPERIMENTAL

KT110

Intervention Type: DRUG

Subjects will receive KT110 on day 1 of period 1 or on day 1 of period 2 depending on randomization.

Prazosin + cyproheptadine

Subjects will be randomized to receive prazosin + cyproheptadine on period 1 or period 2

Group Type: EXPERIMENTAL

Prazosin + cyproheptadine

Intervention Type: DRUG

Subjects will receive prazosin + cyproheptadine on day 1 of period 1 or on day 1 of period 2 depending on randomization.

Interventions

Prazosin + cyproheptadine

Subjects will receive prazosin + cyproheptadine on day 1 of period 1 or on day 1 of period 2 depending on randomization.

Intervention Type: DRUG

KT110

Subjects will receive KT110 on day 1 of period 1 or on day 1 of period 2 depending on randomization.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kinnov Therapeutics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurofins Optimed

Gières, , France

Countries

France

Other Identifiers

OP111821.KIN

Identifier Type: -

Identifier Source: org_study_id