Plaque Psoriasis Vulgaris Clinical Trial
Official title:
A Phase I Study To Assess The Absolute Bioavailability Of A Single Oral Dose Of AZD0284 And To Assess The Pharmacokinetics Of A Single Intravenous Microdose Of [14C]AZD0284 In Healthy Subjects.
The Sponsor is developing the study drug, AZD0284, for the potential treatment of Plaque
psoriasis. Psoriasis is a skin condition that causes red, flaky, crusty patches of skin
covered with silvery scales. It occurs when skin cells are replaced more quickly than usual.
The seriousness of psoriasis varies greatly from person to person. For some people it is a
minor irritation, but for others it can have a major impact on their quality of life. .
The purpose of the study is to determine how much of AZD0284 is taken up by the body. The
safety and tolerability of the drug will also be assessed. It is hoped that the study drug
will improve the management of psoriasis.
The study is a Phase I, single centre, open-label, non-randomized, single dose study
performed in 6 healthy male subjects aged 18 to 65 years, inclusive. The study will assess
the absolute bioavailability of a single oral dose of AZD0284 and the pharmacokinetics (PK)
of a single intravenous (IV) microdose of [14C]AZD0284 in healthy male and female subjects.
Oral AZD0284 and [14C] AZD0284 intravenous solution are referred to as the investigational
products in this study.
A screening visit to assess the eligibility of the healthy male and female subjects will
occur within 28 days of the administration of the investigational product. Screening
assessments will include medical history, inclusion/exclusion criteria, demographic data,
weight and height, vein assessment, physical examination, blood samples for haematology,
clinical chemistry and virology, blood test to confirm post-menopausal status (if female and
of non-childbearing potential), blood test to confirm no history of tuberculosis, urine
sample for urinalysis, urine test for pregnancy (if female and of childbearing potential)
drug screen, alcohol breath test, carbon monoxide (CO) breath test, heart monitoring using
ECG, vital signs (blood pressure, heart rate) Study related procedures will only be
performed after signing of the Informed Consent Form.
The healthy male and female subjects will be admitted to the study centre the day before
administration of the investigational product (Day -1). On Day 1, subjects will be dosed
with a single oral dose of 4 to 120 mg AZD0284 oral suspension (Regimen A) followed by 20 μg
[14C]AZD0284 solution for IV infusion (Regimen B) beginning 3 hours after the oral dose has
been administered. The IV microdose will be infused over 15 minutes and the end of the
infusion is expected to be around the predicted tmax of Regimen A.
The subjects will remain in the study centre until the 48 hour post dose PK blood sample is
obtained. A follow up visit will occur 5 to 7 days after dosing and will include PK and
routine safety assessments.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03310320 -
Study to Determine if AZD0284 is Effective and Safe in Treating Plaque Psoriasis
|
Phase 1 | |
| Completed |
NCT02976831 -
Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD0284 in Healthy Subjects
|
Phase 1 |