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A Single Dose-escalation Study of Cytisine in Adult Smokers

NCT03848208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2020-09-17

Study results available
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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.

Conditions

  • Smoking Cessation

Interventions

DRUG

cytisine

cytisine film-coated oral tablet

DRUG

placebo

matching placebo oral tablet

Sponsors & Collaborators

  • Achieve Life Sciences

    lead INDUSTRY

Principal Investigators

  • Marlene Fonseca, MD · Hospital da Prelada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2019-09-12
Completion
2019-09-12
FDA Drug
Yes

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Drugs

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 NCT03848208 on ClinicalTrials.gov