A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine

NCT06147622 | Completed Phase 1 DMC

• 1 other identifier: OP111821.KIN
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• AUC (area under the curve) 0-t

  Area under the curve from time 0 to the last measurable concentration at time t

  Day 4

• AUC 0-inf

  Area under the curve from time 0 extrapolated to infinity (only for Cyproheptadine)

  Day 4

• Cmax

  Maximum observed concentration

  Day 4

• Tmax

  Time of maximum observed concentration

  Day 4

• T1/2

  Apparent elimination half-life

  Day 4

• K el

  Apparent Elimination rate constant

  Day 4

Study Arms (2)

KT110

EXPERIMENTAL

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

Drug: KT110

Prazosin + cyproheptadine

EXPERIMENTAL

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

Drug: Prazosin + cyproheptadine

Interventions

Prazosin + cyproheptadine DRUG

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

Prazosin + cyproheptadine

KT110 DRUG

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

KT110

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kinnov Therapeutics: lead

Study Sites (1)

Eurofins Optimed

Gières, 38610, France

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Prazosin; Cyproheptadine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open-label, randomized, 2-period, single dose, crossover study

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 27, 2023
• Study Start: April 23, 2024
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)