A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine

Phase 1

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Drug: KT110; Drug: Prazosin + cyproheptadine

• Registration Number: NCT06147622
• Lead Sponsor: Kinnov Therapeutics

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-23
• Study First Posted: 2023-11-27
• Study Start: 2024-04-23
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
KT110	KT110	Subjects will be randomized to receive KT110 on period 1 or period 2
Prazosin + cyproheptadine	Prazosin + cyproheptadine	Subjects will be randomized to receive prazosin + cyproheptadine on period 1 or period 2

Primary Outcome Measures

Name	Time	Method
Cmax	Day 4	Maximum observed concentration
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)
Tmax	Day 4	Time of maximum observed concentration
T1/2	Day 4	Apparent elimination half-life
K el	Day 4	Apparent Elimination rate constant

Trial Locations

Locations (1)

Eurofins Optimed; 🇫🇷 Gières, France