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Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers

NCT05566288 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-05-18

No results posted yet for this study

Summary

The primary objective of this trial is to assess the effects of cytisinicline at therapeutic and supratherapeutic doses on cardiac repolarization relative to placebo in healthy adult subjects who are smokers.

Conditions

  • Smoking Cessation

Interventions

DRUG

Cytisinicline

compressed film-coated tablet containing 3 mg cytisinicline

DRUG

Placebo

Placebo tablets to match compressed film-coated tablet containing 3 mg cytisinicline

DRUG

Moxifloxacin

400 mg tablets

Sponsors & Collaborators

  • Achieve Life Sciences

    lead INDUSTRY

Principal Investigators

  • Marlene Fonseca, MD · Blueclinical, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2022-12-23
Completion
2022-12-23
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 NCT05566288 on ClinicalTrials.gov