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A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers

NCT03303911 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-10-21

Study results available
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Summary

The primary objectives of this study are:

* To evaluate the pharmacokinetic (PK) parameters during repeat dosing of 1.5 mg or 3.0 mg cytisine when administered as the commercial 25-day schedule.
* To evaluate the pharmacodynamic (PD) effects (e.g., reduction in smoking) with repeat dosing of 1.5 mg or 3.0 mg cytisine when administered as the commercial 25-day schedule.

Conditions

  • Smoking Cessation

Interventions

DRUG

Cytisine

film-coated tablets; depending on arm assignment, 1 or 2 tablets to be taken with 240 mL water for each dose

Sponsors & Collaborators

  • Achieve Life Sciences

    lead INDUSTRY

Principal Investigators

  • Annelize Koch, MD · Simbec Research Ltd (Simbec)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-06
Primary Completion
2018-10-05
Completion
2018-10-05
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03303911 on ClinicalTrials.gov