Immunomonitoring of Cyclosporin A in healthy volunteers

Completed

• Conditions: Renal transplantation

• Registration Number: NL-OMON23897
• Lead Sponsor: CHDR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

1.Willing to give written informed consent and willing and able to comply with the study protocol;
2.Healthy male or female subjects, 18 to 55 years of age (inclusive) at screening. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease following a detailed medical history and a complete physical examination including vital signs, laboratory measurements and 12-lead ECG;
3.Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum bodyweight of 50 kg;
4.All women of child bearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment;
5.Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

Exclusion Criteria

1.Any disease associated with immune system impairment, including auto-immune diseases, HIV, any confirmed history of severe allergic reaction and transplantation patients;
2.Evidence of any other active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator. Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance;
3.Clinically significant abnormalities, as judged by the investigator, in laboratory test results
4.Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening, or other known infection requiring antibiotic therapy within the last three months prior to the study;
5.Use of any medications (prescription or over-the-counter [OTC]), within 21 days of study drug administration, or less than 5 half-lives (whichever is longer).
6.Received immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study;
7.Use of any vitamin, mineral, herbal, and dietary supplements within 7 days of study drug administration, or less than 5 half-lives (whichever is longer).
8.Use of oral hormonal contraception within 30 days prior to enrollment or planned to use during the course of the study;
9.Any nutrients known to modulate CYP enzyme activity, such as grapefruit(juice), bitter lemon or tonic within 3 days of study drug administration;
10.Participation in an investigational drug or device study within 3 months prior to first dosing;
11.History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 14 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent;
12.Positive test for drugs of abuse at screening or pre-dose;
13.Alcohol will not be allowed from at least 24 hours before screening and every return visit;
14.Smoking cigarettes (or equivalent) and/or using nicotine based products within 3 months prior to study drug administration;
15.Is demonstrating excess in xanthine consumption (more than eight cups of coffee or equivalent per day) from 7 days prior to the first dose of the study drug until EOS;
16.Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable);
17.Loss or donation of blood over 500 mL within three months prior to screening or intention to donate blood or blood products during the study;
18.If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study;
19.Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic endpoints:<br>-Whole blood cyclosporine A levels<br>-Cellular cyclosporine A levels<br><br>Pharmacodynamic endpoints:<br>-T cell activation<br>-T cell proliferation<br>-Cytokine production<br>