NCT06147622

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Kinnov Therapeutics · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Prazosin + cyproheptadine	Subjects will receive prazosin + cyproheptadine on day 1 of period 1 or on day 1 of period 2 depending on randomization.
DRUG	KT110	Subjects will receive KT110 on day 1 of period 1 or on day 1 of period 2 depending on randomization.

Timeline

• Start date: 2024-04-23
• Primary completion: 2024-07-31
• Completion: 2024-12-31
• First posted: 2023-11-27
• Last updated: 2025-03-13

Locations

1 site across 1 country: France