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NCT06147622 | COMPLETED | Alcohol Use Disorder

A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine
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

Condition or disease

Alcohol Use Disorder

Intervention/treatment

Prazosin + cyproheptadine

KT110

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : NONE
Primary Purpose : OTHER
Official 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
Actual Study Start Date : 2024-04-23
Estimated Primary Completion Date : 2024-07-31
Estimated Study Completion Date : 2024-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine

Location Details

NCT06147622

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How to Participate

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Locations

Not yet recruiting

France,

Eurofins Optimed

Gières, France, 38610