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A Phase I, Double-blind, Randomized, Placebo-controlled, Single Dose-escalation Study to Evaluate the Tolerability and Safety of Cytisine in Adult Smokers

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Trial Profile

A Phase I, Double-blind, Randomized, Placebo-controlled, Single Dose-escalation Study to Evaluate the Tolerability and Safety of Cytisine in Adult Smokers

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 18 Sep 2020

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At a glance

  • Drugs Cytisinicline (Primary)
  • Indications Smoking withdrawal
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Achieve Life Sciences

Most Recent Events

  • 30 Sep 2019 Results published in the Achieve Life Sciences Media Release.
  • 30 Sep 2019 According to an Achieve Life Sciences media release, this study is required by the FDA as part of a New Drug Application (NDA) for Cytisinicline for marketing approval in the United States.
  • 30 Sep 2019 According to an Achieve Life Sciences media release, at 30mg dose the the stopping criteria of serious or severe AEs were still not met, but the Data Safety Monitoring Committee (DSMC) recommended stopping the study as the frequency of gastrointestinal symptoms were approaching a maximum tolerated dose. Also the results will be reviewed with the FDA to determine if further escalation beyond 30 mg will be required.

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