A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine

Study Overview
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Brief Summary
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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, 1 tablet containing 10 mg of Prazosin and 12 mg of Cyproheptadine - wash-out period - Period 2: Alpress and Periactin marketed tablets, 2 tablets of 5 mg Prazosin and 3 tablets of 4 mg Cyproheptadine; Or; (B) Period 1: Alpress and Periactin marketed tablets, 2 tablets of 5 mg Prazosin and 3 tablets of 4 mg Cyproheptadine - wash-out period - Period 2: KT110, 1 tablet containing 10 mg of Prazosin and 12 mg of Cyproheptadine.

Official Title
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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

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Prazosin + cyproheptadine
* Drug: KT110


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: open-label, randomized, 2-period, single dose, crossover study
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |