rheumatoid arthritis MedDRA version: 9.1 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions
Conditions
Interventions
Product Code: AZD5672
Pharmaceutical Form: Tablet
Current Sponsor code: AZD5672
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the place
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Provision of informed consent prior to any study specific procedures. 2.Male aged between 18 and 45 years (inclusive). 3.Body Mass Index (BMI) of between 18 and 30 kg/m2. Minimum weight 50 kg. 4.Non-smoker. For inclusion in the genetic component of the study, subjects must fulfil the following additional criterion: 1.Provision of signed, written and dated informed consent for genetic research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 2.Previous randomisation to treatment in the present study. 3.Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to dosing (whichever is longer). Healthy volunteers involved in non-drug methodology studies (either invasive or non-invasive) may be included without delay, at the discretion of the investigator. Consideration should be given to a longer washout for biological agents 4.History of additional risk factors for Torsade de Pointes (e.g. heart failure, hypokalemia, personal or family history of arrhythmia or long QT syndrome). 5.Marked QTc prolongation at baseline e.g. repeated demonstration of QTc interval >450 ms or marked shortening of QTcF 5 years ago. 13.Known or suspected drug abuse or positive drugs of abuse test. 14.History of excessive alcohol consumption. Excessive intake of alcohol is defined as a regular maximum weekly intake of greater than 28 units for men and 21 units for women (where 1 unit equals a half pint (285 mL) of beer or a glass of wine (125 mL) or a single measure of spirits (25 mL)). 15.If participation in the study would result in the subject donating more than 1350 mL of blood in the 12 months or 500 mL of blood in the 3 months before the end of the study. 16.Whole blood transfusion within 120 days of the date of genetic sample collection. 17.Use of prescribed medication (including IV and oral antibiotics (prescribed or over-the-counter), live/live-attenuated vaccines or St John’s Wort) in the 4 weeks prior to dosing or use of over-the-counter drugs (including herbals, vitamins and minerals) 1 week prior to dosing (excluding occasional paracetamol use). 18.Acute illness or surgical procedure within the 2 weeks prior to dosing in the opinion of the investigator or his/her dele
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the change in time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo. ;Primary end point(s): To evaluate the change in time-matched QTcF intervals of single dose AZD5672 600 mg compared to placebo. ;Secondary Objective: 1.To evaluate the change in time-matched QT intervals of single dose AZD5672 150mg compared to placebo. 2.To evaluate the change in time matched ECG parameters (QTcB, QTcX, RR, PR and QRS) of single dose AZD5672 600mg and 150mg compared to placebo. 3.To assess the pharmacokinetics of single dose AZD5672 600mg and 150mg in healthy volunteers. 4.To evaluate the safety and tolerability of single dose AZD5672 600mg and 150mg | — |
Countries
United Kingdom
Outcome results
None listed