Plaque Psoriasis VulgarisPhase 1NCT03029741
Bioavailability of AZD0284 and IV Microtracer Study
A Phase 1 study testing AZD0284 and [14C]AZD0284 in people with Plaque Psoriasis Vulgaris, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis Vulgaris
- What is being tested?
- AZD0284 and [14C]AZD0284
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2017to 23 Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated, written informed
- Healthy males or non-pregnant, non-lactating healthy females.
- Age 18 to 65 years of age.
- Suitable veins for cannulation or repeated venepuncture.
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
- Post-menopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the postmenopausal range.
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- Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Body mass index of 18.0 to 30.0 kg/m2, inclusive, or, if outside the range, considered not clinically significant by the investigator, and weigh at least 50 kg and no more than 100 kg, inclusive.
- Must be willing and able to communicate and participate in the whole study.
- Must agree to use an adequate method of contraception
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results of the volunteer's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
- Subject who have increased risk of infection History and/or presence of tuberculosis (TB) positive result for IFN-y release assay (IGRA) (ie QuantiFERON TB-Gold). The test may be repeated if the initial test result is indeterminate.
- Is in a high-risk group for human immunodeficiency virus (HIV) infection within the last 6 months.
- Subjects with a disease history suggesting abnormal immune function in the judgement of the investigator. (This does not include mild allergy such as childhood asthma or eczema).
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- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis, as judged by the investigator.
- Any clinically significant abnormal findings in vital signs, as judged by the investigator.
- Any clinically significant abnormal findings in 12-lead ECG, as judged by the investigator.
- Any positive result at screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or HIV results.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Plaque Psoriasis Vulgaris
- Being tested
- AZD0284, [14C]AZD0284
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0284Drug
Subjects will receive a single oral dose of 4 to 120 mg AZD0284 oral suspension 5 mg/mL in the fasted state
[14C]AZD0284Drug
Following administration of the AZD0284 oral suspension subjects will receive an IV infusion of 20 μg [14C]AZD0284 solution
| Study group | Role | What they receive |
|---|---|---|
| Bioavailability of AZD0284 | Experimental | To assess the absolute bioavailability of a single oral dose of AZD0284 in healthy subjects.
To assess the pharmacokinetics (PK) of a single intravenous (IV) microdose of [14C]AZD0284 in healthy subjects. Receives: Drug: AZD0284; Drug: [14C]AZD0284 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of absolute bioavailability of AZD0284
Absolute bioavailability of AZD0284 will be calculated from area under the plasma concentration versus time curve (AUC) of the oral dose of AZD0284 / AUC of the IV dose of [14C]AZD x IV dose/Oral dose x 100
Measured: PK blood samples: pre-dose, post oral dosing at hour, 0.5, 1, 2, 0, 0.5, 1, 2, 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5,3.75, 4, 5, 6, 7, 8, 9, 11, 12, 15, 24, 27, 36, 48 and 72.
Cmax for [14C]AZD0284
Pharmacokinetic (PK) profile of the IV dose of AZD0824 in terms of the maximum observed plasma concentration (Cmax) for [14C]AZD0284
Measured: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Tmax for [14C]AZD0284
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the the time to maximum observed plasma concentration (Tmax) for [14C]AZD0284.
Measured: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
AUC(0-last) for [14C]AZD0284
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the area under the concentration-time curve from dosing to the last measurable concentration for [14C]AZD0284.
Measured: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
AUC(0-inf) for [14C]AZD0284
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms the area under the concentration-time curve from dosing extrapolated to infinity for [14C]AZD0284.
Measured: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
AUC%extrap for [14C]AZD0284
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the percentage of AUC(0-inf) extrapolated beyond the last measured for [14C]AZD0284.
Measured: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
lambda-z for [14C]AZD0284
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the terminal elimination rate constant calculated from the slope of the apparent elimination phase for [14C]AZD0284.
Measured: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
T1/2 for [14C]AZD0284
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the apparent terminal elimination half-life for [14C]AZD0284.
Measured: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
CL (total clearance) for [14C]AZD0284
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the terminal elimination rate constant calculated from the slope of the apparent elimination phase for [14C]AZD0284
Measured: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Vz for [14C]AZD0284
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the volume of distribution at steady state for [14C]AZD0284.
Measured: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Vss for [14C]AZD0284
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the volume of distribution at steady state for [14C]AZD0284.
Measured: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
MRT (mean residence time) for [14C]AZD0284
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the mean residence time for [14C]AZD0284.
Measured: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Cmax for AZD0284
Pharmacokinetic (PK) profile of the oral dose of AZD0824 in terms of the maximum observed plasma concentration (Cmax) for AZD0284.
Measured: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Tmax for AZD0284
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the the time to maximum observed plasma concentration (Tmax) for AZD0284.
Measured: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Tlag for AZD0284
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the elapsed time from dosing at which the analyte was first quantifiable in a concentration vs time profile for AZD0284.
Measured: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
AUC (0-last) for AZD0284
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the area under the concentration-time curve from dosing to the last measurable concentration for AZD0284.
Measured: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
AUC(0-inf) for AZD0284
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms the area under the concentration-time curve from dosing extrapolated to infinity for AZD0284.
Measured: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
AUC%extrap for AZD0284
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the percentage of AUC(0-inf) extrapolated beyond the last measured time point for AZD0284.
Measured: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
lambda-z for AZD0284
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the terminal elimination rate constant calculated from the slope of the apparent elimination phase for AZD0284.
Measured: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
T1/2 for AZD0284
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the apparent terminal elimination half-life for AZD0284.
Measured: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
CL/F for AZD0284
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the apparent total clearance for AZD0284.
Measured: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 36, 48 and 72.
Vz/F for AZD0284
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the apparent volume of distribution for AZD0284.
Measured: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 , 36, 48 and 72.
MRT for AZD0284
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms the mean residence time for AZD0284.
Measured: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Secondary outcomes (5)
To collect further information about the safety and tolerability of AZD0284 by assessing physical examinations.
Physical examination will be carried out by a fully registered physician at the clinical unit.
Measured: Targeted physical examination:screening, pre-dose, time relative to oral dosing at hour 72.
To collect further information about the safety and tolerability of AZD0284 by assessing telemetry
ECGs will be taken in the clinic by a trained research nurse or a trained clinical technician and reviewed by a physician.
Measured: Continuous ECG monitoring will commence approximately 10 minutes before dosing commences until 24 hours after the oral dose.
To collect further information about the safety and tolerability of AZD0284 by assessing safety laboratory tests
Collected by a research nurse or trained clinical technician at the clinical unit.
Measured: Haematology and clinical chemistry:screening, pre-dose, time relative to oral dosing at hour 24 and 72, virology at screening.
To collect further information about the safety and tolerability of AZD0284 by assessing vital signs
Vital signs will be measured using manual and automated devices by trained staff at the clinical unit.
Measured: Blood pressure and pulse rate: screening, pre-dose, post oral dosing at hour 1, 2, 3, 4, 6, 8, 12, 24 and 72.
To collect further information about the safety and tolerability of AZD0284 by assessing 12 Lead Electrocardiogram (ECG)
ECGs will be taken in the clinic by a trained research nurse or a trained clinical technician and reviewed by a physician.
Measured: ECGs: screening, pre-dose, post oral dosing at hour, 1, 2, 3, 4, 6, 8, 12, 24 and follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start21 Feb 2017
- Primary completion23 Mar 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Evans, MBChB, MRCS, Principal investigator, Quotient Clinical Ltd, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029741
- Sponsor's protocol ID
- D7800C00002
- Other IDs
- 2016-004260-19, 2016
- Status last verified
- Apr 2017
- First submitted
- 20 Jan 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03029741
- Acronym / sponsor ID
- D7800C00002
- Conditions
- Plaque Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioavailability of AZD0284 | Experimental | Drug: AZD0284, Drug: [14C]AZD0284To assess the absolute bioavailability of a single oral dose of AZD0284 in healthy subjects. To assess the pharmacokinetics (PK) of a single intravenous (IV) microdose of [14C]AZD0284 in healthy subjects. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed and dated, written informed
- Healthy males or non-pregnant, non-lactating healthy females.
- Age 18 to 65 years of age.
- Suitable veins for cannulation or repeated venepuncture.
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
Key exclusion criteria (10 listed)
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results of the volunteer's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
- Subject who have increased risk of infection History and/or presence of tuberculosis (TB) positive result for IFN-y release assay (IGRA) (ie QuantiFERON TB-Gold). The test may be repeated if the initial test result is indeterminate.
- Is in a high-risk group for human immunodeficiency virus (HIV) infection within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0284Subjects will receive a single oral dose of 4 to 120 mg AZD0284 oral suspension 5 mg/mL in the fasted state | Drug | Bioavailability of AZD0284 |
| [14C]AZD0284Following administration of the AZD0284 oral suspension subjects will receive an IV infusion of 20 μg [14C]AZD0284 solution | Drug | Bioavailability of AZD0284 |
Primary outcome
Determination of absolute bioavailability of AZD0284
Time frame: PK blood samples: pre-dose, post oral dosing at hour, 0.5, 1, 2, 0, 0.5, 1, 2, 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5,3.75, 4, 5, 6, 7, 8, 9, 11, 12, 15, 24, 27, 36, 48 and 72.
Absolute bioavailability of AZD0284 will be calculated from area under the plasma concentration versus time curve (AUC) of the oral dose of AZD0284 / AUC of the IV dose of [14C]AZD x IV dose/Oral dose x 100
Cmax for [14C]AZD0284
Time frame: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Pharmacokinetic (PK) profile of the IV dose of AZD0824 in terms of the maximum observed plasma concentration (Cmax) for [14C]AZD0284
Tmax for [14C]AZD0284
Time frame: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the the time to maximum observed plasma concentration (Tmax) for [14C]AZD0284.
AUC(0-last) for [14C]AZD0284
Time frame: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the area under the concentration-time curve from dosing to the last measurable concentration for [14C]AZD0284.
AUC(0-inf) for [14C]AZD0284
Time frame: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms the area under the concentration-time curve from dosing extrapolated to infinity for [14C]AZD0284.
AUC%extrap for [14C]AZD0284
Time frame: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the percentage of AUC(0-inf) extrapolated beyond the last measured for [14C]AZD0284.
lambda-z for [14C]AZD0284
Time frame: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the terminal elimination rate constant calculated from the slope of the apparent elimination phase for [14C]AZD0284.
T1/2 for [14C]AZD0284
Time frame: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the apparent terminal elimination half-life for [14C]AZD0284.
CL (total clearance) for [14C]AZD0284
Time frame: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the terminal elimination rate constant calculated from the slope of the apparent elimination phase for [14C]AZD0284
Vz for [14C]AZD0284
Time frame: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the volume of distribution at steady state for [14C]AZD0284.
Vss for [14C]AZD0284
Time frame: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the volume of distribution at steady state for [14C]AZD0284.
MRT (mean residence time) for [14C]AZD0284
Time frame: PK blood samples:pre-dose, time relative to oral dosing at hour: 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5, 3.75, 4, 5, 6, 7, 8, 9, 11, 15, 27, 36, 48 and 72.
Pharmacokinetic (PK) profile of the IV dose of AZD0284 in terms of the mean residence time for [14C]AZD0284.
Cmax for AZD0284
Time frame: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Pharmacokinetic (PK) profile of the oral dose of AZD0824 in terms of the maximum observed plasma concentration (Cmax) for AZD0284.
Tmax for AZD0284
Time frame: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the the time to maximum observed plasma concentration (Tmax) for AZD0284.
Tlag for AZD0284
Time frame: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the elapsed time from dosing at which the analyte was first quantifiable in a concentration vs time profile for AZD0284.
AUC (0-last) for AZD0284
Time frame: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the area under the concentration-time curve from dosing to the last measurable concentration for AZD0284.
AUC(0-inf) for AZD0284
Time frame: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms the area under the concentration-time curve from dosing extrapolated to infinity for AZD0284.
AUC%extrap for AZD0284
Time frame: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the percentage of AUC(0-inf) extrapolated beyond the last measured time point for AZD0284.
lambda-z for AZD0284
Time frame: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the terminal elimination rate constant calculated from the slope of the apparent elimination phase for AZD0284.
T1/2 for AZD0284
Time frame: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the apparent terminal elimination half-life for AZD0284.
CL/F for AZD0284
Time frame: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 36, 48 and 72.
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the apparent total clearance for AZD0284.
Vz/F for AZD0284
Time frame: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 , 36, 48 and 72.
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms of the apparent volume of distribution for AZD0284.
MRT for AZD0284
Time frame: PK blood samples: pre-dose, time relative to oral dosing at hour, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72.
Pharmacokinetic (PK) profile of the oral dose of AZD0284 in terms the mean residence time for AZD0284.
5 secondary outcomes
To collect further information about the safety and tolerability of AZD0284 by assessing physical examinations.
Time frame: Targeted physical examination:screening, pre-dose, time relative to oral dosing at hour 72.
To collect further information about the safety and tolerability of AZD0284 by assessing telemetry
Time frame: Continuous ECG monitoring will commence approximately 10 minutes before dosing commences until 24 hours after the oral dose.
To collect further information about the safety and tolerability of AZD0284 by assessing safety laboratory tests
Time frame: Haematology and clinical chemistry:screening, pre-dose, time relative to oral dosing at hour 24 and 72, virology at screening.
To collect further information about the safety and tolerability of AZD0284 by assessing vital signs
Time frame: Blood pressure and pulse rate: screening, pre-dose, post oral dosing at hour 1, 2, 3, 4, 6, 8, 12, 24 and 72.
To collect further information about the safety and tolerability of AZD0284 by assessing 12 Lead Electrocardiogram (ECG)
Time frame: ECGs: screening, pre-dose, post oral dosing at hour, 1, 2, 3, 4, 6, 8, 12, 24 and follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Evans, MBChB, MRCS principal investigator
Quotient Clinical Ltd, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD0284 and [14C]AZD0284 in people with Plaque Psoriasis Vulgaris, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of absolute bioavailability of AZD0284 (time frame: PK blood samples: pre-dose, post oral dosing at hour, 0.5, 1, 2, 0, 0.5, 1, 2, 2.83, 2.92, 2.92, 3, 3.08, 3.17, 3.33, 3.5,3.75, 4, 5, 6, 7, 8, 9, 11, 12, 15, 24, 27, 36, 48 and 72.). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.