A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine

Alcohol Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06147622
• Other study ID #: OP111821.KIN
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Greenpharma S.A.S.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Prazosin + cyproheptadine
Subjects will receive prazosin + cyproheptadine on day 1 of period 1 or on day 1 of period 2 depending on randomization.
• KT110
Subjects will receive KT110 on day 1 of period 1 or on day 1 of period 2 depending on randomization.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kinnov Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (area under the curve) 0-t	Area under the curve from time 0 to the last measurable concentration at time t	Day 4
Primary	AUC 0-inf	Area under the curve from time 0 extrapolated to infinity (only for Cyproheptadine)	Day 4
Primary	Cmax	Maximum observed concentration	Day 4
Primary	Tmax	Time of maximum observed concentration	Day 4
Primary	T1/2	Apparent elimination half-life	Day 4
Primary	K el	Apparent Elimination rate constant	Day 4