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A Study to Assess the Effect of Fluvoxamine and Smoking on Pharmacokinetics ( the Movement of Drugs Within the Body) of AZD4635 in Healthy Volunteers

NCT04478513 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-01-06

No results posted yet for this study

Summary

This study is a Phase I, open-label, non-randomized, 2-period, fixed-sequence study in healthy volunteers who are either smokers or non-smokers, performed at a single Clinical Unit.

Conditions

  • Healthy Volunteer/DDI Study

Interventions

DRUG

AZD4635

During each treatment period subjects will receive a single dose of AZD4635 under fasting conditions.

DRUG

Fluvoxamine

Daily oral single doses of fluvoxamine are planned to be administered to healthy volunteers in Treatment Period 2.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Pablo Forte Soto, Dr. · Parexel Early Phase Clinical Unit London

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2020-12-23
Completion
2020-12-23

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT04478513 on ClinicalTrials.gov