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Completed

NCT Number: NCT06147622

A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine

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

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eurofins Optimed

Gières, 38610, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prazosin + cyproheptadine

Drug

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

KT110

Drug

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

Primary outcomes

  1. AUC (area under the curve) 0-t

    Time frame: Day 4

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

  2. AUC 0-inf

    Time frame: Day 4

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

  3. Cmax

    Time frame: Day 4

    Maximum observed concentration

  4. Tmax

    Time frame: Day 4

    Time of maximum observed concentration

  5. T1/2

    Time frame: Day 4

    Apparent elimination half-life

  6. K el

    Time frame: Day 4

    Apparent Elimination rate constant

Sponsors and collaborators

Lead sponsor

Kinnov Therapeutics

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 27, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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