drugset
drugset / Trial / NCT03848208

A Single Dose-escalation Study of Cytisine in Adult Smokers

NCT03848208 ↗

Phase 1 Completed 74 enrolled Achieve Life Sciences
RandomizedParallel-groupDouble-blindTreatment

Summary

The objectives of this study are: 1. To assess the tolerability and safety of cytisine as a single oral dose. 2. To define the Cmax levels associated to the occurrence of dose-limiting adverse events.

Timeline

Start
2019-02-28
Primary completion
2019-09-12
Completion
2019-09-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytisinicline Small molecule 6 mg Oral
Subject Cytisinicline Small molecule 9 mg Oral
Subject Cytisinicline Small molecule 12 mg Oral
Subject Cytisinicline Small molecule 15 mg Oral
Subject Cytisinicline Small molecule 18 mg Oral
Subject Cytisinicline Small molecule 21 mg Oral
Subject Cytisinicline Small molecule 24 mg Oral
Subject Cytisinicline Small molecule 27 mg Oral
Subject Cytisinicline Small molecule 30 mg Oral

Indications

No indication recorded.