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

STATUS

Recruiting
participants needed

28
sponsor

AstraZeneca

Updated on 19 February 2024

See if I qualify

Summary

Show definitions

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.

Description

The study will comprise:

A screening period of up to 28 days;
Two treatment periods lasting a total of 17 days from admission to the Clinical Unit (Day -1) to discharge (Day 16). During each treatment period subjects will receive a single dose of AZD4635 under fasting conditions. Period 1 is designed to evaluate the pharmacokinetics (PK) of AZD4635 in healthy smokers and nonsmokers. Period 2 is designed to evaluate the effect of fluvoxamine on the PK of AZD4635 in healthy smokers and non-smokers.
A follow-up call will take place between 6 to 9 days after the last dose of fluvoxamine, to ensure the well-being of the subjects. Completion of the last follow-up call or unscheduled follow-up visit will be considered the end of the study.

Each subject will be involved in the study for a maximum of 53 days.

Details

Condition	Healthy Volunteer/DDI Study
Age	18years - 55years
Treatment	AZD4635, Fluvoxamine
Clinical Study Identifier	NCT04478513
Sponsor	AstraZeneca
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Provision of signed and dated, written informed consent prior to any study specific procedures
	Healthy male and female subjects of non-childbearing potential subjects aged 18 - 55 years (inclusive at screening) with suitable veins for cannulation or repeated venipuncture
	Have a body mass index (BMI) between 18.5 and 32.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive
	Willingness and ability to comply with study and follow-up procedures
	Subjects who are recruited as non-smokers should have no history of smoking cigarettes for >6 months and test negative for urine cotinine levels at screening and admission
	Subjects who are recruited as smokers must have a history of smoking >10 cigarettes/day for >6 months and have urine cotinine levels over 500 ng/ml at screening and admission
Exclusion Criteria
	History of any clinically significant disease or disorder which, in the opinion of the principal investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
	History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
	History of cardiac disease; concurrent electroconvulsive therapy, diabetes mellitus, epilepsy, bleeding disorders (especially GI bleeding), mania and susceptibility to angle-closure glaucoma
	Presence of refractory nausea and vomiting or chronic GI diseases
	Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP)
	Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the PI (based on laboratory parameters)
	Any clinically significant abnormal findings in vital signs at screening as judged by the PI
	Systolic blood pressure (BP) >140 and/or diastolic BP > 90 mmHg, or history of hypertension at screening
	Any confirmed clinically significant abnormalities on 12-lead ECG at screening, as judged by the PI
	Haemoglobin A1c (HbA1c) >5.7% at the screening visit
	Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibodies
	Known or suspected history of drug abuse, within the past 2 years, as judged by the PI
	Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study
	Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening
	History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI
	Positive screen for drugs of abuse at screening or admission to the study centre
	Use of herbal preparations/medications within 14 days prior to the administration of the first dose of AZD4635
	Subject who has had prescription or non-prescription drugs or other products known to be sensitive to Breast cancer resistance protein
	Use of any prescribed or non prescribed medication including antacids, analgesics, herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP
	Subjects who have involvement with AstraZeneca or Parexel or are study site employee or their close relatives
	Subjects who have previously been enrolled in this study or have previously received AZD4635
	Judgment by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements

How to participate?

Step 1 Connect with a study center

Send a message

Enter your contact details to connect with study team

First name*

Last name*

Email*

Phone number*

Other language

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

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

Summary

Description

Details

How to participate?

Similar trials to consider

Not finding what you're looking for?

Study AnnotationsStudy Notes

Add a private note

Study Definition

Add a private note

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

Summary

Description

Details

How to participate?

Similar trials to consider

Not finding what you're looking for?

Sign up as a volunteer to stay informed

Study AnnotationsStudy Notes

Add a private note

Study Definition

Add a private note