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Study to Evaluate Effect of Food on Bioavailability of Single 3 mg Tablet and Pharmacokinetics (PK) of Multiple 3 mg Doses in Healthy Adult Smokers

NCT05981768 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-18

No results posted yet for this study

Summary

To assess the effect of food on the bioavailability of 3 mg cytisinicline following single-dose administration, and to evaluate the PK profile of 3 mg cytisinicline TID following multiple days of administration during Days 5-8.

Conditions

  • Smoking Cessation

Interventions

DRUG

Cytisinicline

film-coated oral tablets containing 3 mg cytisinicline

Sponsors & Collaborators

  • Achieve Life Sciences

    lead INDUSTRY

Principal Investigators

  • Marlene Fonseca, MD · Blue Clinical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-08
Primary Completion
2023-09-21
Completion
2023-09-21
FDA Drug
Yes

Countries

  • Portugal

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 NCT05981768 on ClinicalTrials.gov