Recent Updates
Recently added Catalysts

AZD6140

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 13, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01588626Study to Assess the Pharmacokinetics of AZD6140 After Single Dose in Healthy Japanese Male VolunteersPHASE1 COMPLETED 12 — — May 1, 2012Jun 1, 2012Jul 13, 20121 Japan
NCT00685906AZD6140 Oral Contraceptive Interaction StudyPHASE1 COMPLETED 24 — — Apr 1, 2008Oct 1, 2008Dec 2, 20101 United States
Unlock Drug Trial Details
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)
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.
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
Blood levels of various other hormones following concomitant 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 and its main metabolite after concomitant oral administration of AZD6140 and Nordette®
At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2.
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AZD6140EXPERIMENTALsingle administration of 90 mg dose of AZD6140
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
AZD6140DRUGtablet
Levonorgestrel and Ethinyl Estradiol (Nordette®)DRUG1 tablet taken by mouth once a day for 28 days per cycle
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 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:JapanUnited States
Unlock Eligibility Criteria