A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine

A Phase 1, Open-label, Cross-over Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine Following Single Dose Oral Administration of KT110 Tablet and Following Administration of Alpress and Periactin Marketed Tablets

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

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: KT110; Drug: Prazosin + cyproheptadine

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Gières, France, 38610
    • Eurofins Optimed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KT110; Subjects will be randomized to receive KT110 on period 1 or period 2	Drug: KT110; Subjects will receive KT110 on day 1 of period 1 or on day 1 of period 2 depending on randomization.
Experimental: Prazosin + cyproheptadine; Subjects will be randomized to receive prazosin + cyproheptadine on period 1 or period 2	Drug: Prazosin + cyproheptadine; Subjects will receive prazosin + cyproheptadine on day 1 of period 1 or on day 1 of period 2 depending on randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
AUC (area under the curve) 0-t	Area under the curve from time 0 to the last measurable concentration at time t	Day 4

Collaborators and Investigators

• Sponsor: Kinnov Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2024
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 23, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Dermatologic Agents; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Adrenergic Agents; Anti-Allergic Agents; Antipruritics; Serotonin Antagonists; Serotonin Agents; Antihypertensive Agents; Adrenergic Antagonists; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Histamine H1 Antagonists; Cyproheptadine; Prazosin
• Other Study ID Numbers: OP111821.KIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No