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AZD6140

Phase 1

Blood Flow Speed | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Jul 13, 2012

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

AZD6140 · 6 trials · 7 indications

Phase 1 6
NCT01588626Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male VolunteersHealthy
COMPLETED12 Analytics
NCT01226602Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.Blood Flow Speed
COMPLETED39 Analytics
NCT00721448An Open-Label, Single and Multiple Dose Pharmacokinetic Study of 90 mg and 180 mg Doses of AZD6140 in Healthy VolunteersPharmacokinetics
COMPLETED24 Analytics
NCT00738842Uric Acid Study in Healthy Male VolunteersGout
COMPLETED24 Analytics
NCT00685906AZD6140 Oral Contraceptive Interaction StudyHealthy
COMPLETED24 Analytics
NCT00733265Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy VolunteersRenal Impairment
COMPLETED24 Analytics
PHASE1COMPLETED
Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
Study to Assess the Effect of Ticagrelor on Coronary Blood Flow in Healthy Male Subjects.
Blood Flow SpeedUnlock trial analytics
PHASE1COMPLETED
An Open-Label, Single and Multiple Dose Pharmacokinetic Study of 90 mg and 180 mg Doses of AZD6140 in Healthy Volunteers
PharmacokineticsUnlock trial analytics
PHASE1COMPLETED
Uric Acid Study in Healthy Male Volunteers
GoutUnlock trial analytics
PHASE1COMPLETED
AZD6140 Oral Contraceptive Interaction Study
HealthyUnlock trial analytics
PHASE1COMPLETED
Study to Investigate the Effects of AZD6140 in Patients With Renal Impairment and in Healthy Volunteers
Renal ImpairmentUnlock trial analytics

Study Endpoints

Primary Endpoints

Description of pharmacokinetics for AZD6140 in terms of: Cmax, tmax, t½, AUC(0-t), AUC, CL/F, Vz/F, MRT, and AUC and Cmax ratios of AR-C124910XX to AZD6140, following single administration of 90 mg dose of AZD6140 in healthy Japanese volunteers.
From day 1 (pre-dose) till Day 4 (72h)

Maximum Concentration (Cmax), Time to reach maximum (peak) plasma concentration (tmax), Terminal plasma half-life (t½), Area under the plasma concentration-time curve from time zero to time t (AUC(0-t)),Area under the plasma concentration-time curve (AUC), Apparent total clearance of the drug from plasma after oral administration (CL/F), Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F), Mean residence time (MRT), and AUC and Cmax ratios of AR-C124910XX to AZD6140,

Description of pharmacokinetics profile for AR-C124910XX, which is AZD6140 active metabolite, in terms of: Cmax, tmax, t½, AUC(0-t), AUC, CL/F, Vz/F, MRT, and AUC, following single administration of 90 mg dose of AZD6140 in healthy Japanese volunteers.
From day 1 (pre-dose) till Day 4 (72h)
Assess the effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity response by estimating the change in area under the adenosine dose response curve before and after study drug.
During 6 h at visit 2
AZD6140 and AR-C124910XX concentration
-2,0,0.5,1,2,3,4,6,8,12,18,24,36,48,72 hours on days 4,5,6,7,8and 9. Day 10 the samples are at the specified timeframes (0,0.5,1,2,3,4,6,8,12,18,24,36,48,72 hours)
The effect of AZD6140 on the levels of certain chemicals in subjects' blood and urine.
Levels or certain chemicals in subjects' blood and urine will be measured at scheduled times during the first 7 days of the study.
Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette®
At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
Blood levels of AZD6140 in patients with severe kidney disease compared to volunteers with normal kidneys
Scheduled times during the 3 days after the study drug is taken

Secondary Endpoints

AZD6140 Safety and tolerability profile in terms of: adverse events, vital signs (blood pressure and pulse rate), electrocardiograms (ECGs), laboratory variables
From Day -1 (pre-dose) up to 7-10 days after dose
Effect of Ticagrelor compared to placebo on the adenosine induced coronary blood flow velocity by estimating the change in area under the adenosine dose response curve before and after infusion of theophylline.
During 6 h at visit 2
Difference in basal blood flow (in the absence of adenosine) between Ticagrelor and placebo conditions before and after infusion of theophylline.
During 6h at visit 2
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AZD6140EXPERIMENTALsingle administration of 90 mg dose of AZD6140
1EXPERIMENTALAdenosinladder; Ticagrelor (180 mg), Adenosinladder ; Theophylline (5 mg/kg), Adenosinladder
2PLACEBO_COMPARATORAdenosinladder; Placebo, Adenosinladder; Theophylline (5 mg/kg), Adenosinladder

Interventions

NameTypeDescription
AZD6140DRUGtablet
PlaceboDRUG -
Placebo to match AZD6140DRUGOral tablets taken bid for 5 days
Levonorgestrel and Ethinyl Estradiol (Nordette®)DRUG1 tablet taken by mouth once a day for 28 days per cycle
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subject aged between 20 to 45 years inclusive * Body mass index (BMI=weight/height2) between 18.0 to 27.0 kg/m2 inclusive * Body weight between 50.0 to 85.0 kg inclusive Provision of written informed consent Exclusion Criteria: * Clinically significant abnormali...

Countries:JapanSwedenChinaUnited States
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Frequently asked questions about AZD6140

What is AZD6140 used for?

AZD6140 is an investigational small molecule being studied for use in gout, renal impairment, and healthy volunteer settings, including pharmacokinetics and blood flow speed. It is in Phase 1 clinical development for these indications. The drug is being developed by AstraZeneca PLC.

What does AZD6140 target?

AZD6140 is a small molecule in the cardiovascular therapeutic area. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its effects on uric acid levels and other cardiovascular-related parameters.

Who makes AZD6140?

AZD6140 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in various patient populations.

What phase is AZD6140 in?

AZD6140 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. All completed trials for AZD6140 are Phase 1 studies, and the drug is not yet available for clinical use outside of research settings.

What clinical trials is AZD6140 in?

AZD6140 has been studied in several completed Phase 1 trials. These include NCT00685906, an oral contraceptive interaction study in healthy women; NCT00733265, a study in patients with renal impairment and healthy volunteers; NCT00738842, a uric acid study in healthy males; and NCT01588626, a pharmacokinetic study in healthy Japanese males.

Is AZD6140 the same as ticagrelor?

AZD6140 is the investigational code name for the drug that is also known as ticagrelor. Ticagrelor is an antiplatelet medication that has been studied in cardiovascular conditions. In the clinical trials listed, AZD6140 is being evaluated for its effects on uric acid and other parameters.