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AZD9742

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 27, 2012

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment119

FDA Designations

No designations recorded

Clinical trial landscape

AZD9742 · 5 trials · 4 indications

Phase 1 5
NCT01154621Assessing the Safety and Tolerability of a Single IV Dose of AZD9742 in Healthy Elderly Male and Female SubjectsTolerability
COMPLETED12 Analytics
NCT01124760Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy VolunteersPharmacokinetics
COMPLETED28 Analytics
NCT01114152AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese SubjectsHealthy
COMPLETED35 Analytics
NCT01064388A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 DaysHealthy
COMPLETED36 Analytics
NCT01030224This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy SubjectsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Assessing the Safety and Tolerability of a Single IV Dose of AZD9742 in Healthy Elderly Male and Female Subjects
TolerabilityUnlock trial analytics
PHASE1COMPLETED
Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers
PharmacokineticsUnlock trial analytics
PHASE1COMPLETED
AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese Subjects
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 Days
HealthyUnlock trial analytics
PHASE1COMPLETED
This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the safety and tolerability of a single intravenous dose of AZD9742 in healthy elderly adults.
The screening period is up to 28 days. Residential period will be a total of 5 days. Follow up will occur between 5 and 10 days after discharge.

Adverse events, vital signs, electrocardiograms, telemetry, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment

Determine the effect of coadministration of CYP3A4 inhibitors (diltiazem and ketoconazole) on the pharmacokinetics of AZD9742 in blood and urine.
For diltiazem group - up to 18 days of pre-defined study days for pk profiling. For keoconazole - up to 14 days of pre-defined study days for pk profiling.
Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
collected prior to treatment, during treatment and follow-up for a total of 18-22 days
Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
Assessments taken at Visit 1 (enrollment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored througout the study from Visit 1 through Visit 3 for adverse events.

Secondary Endpoints

To evaluate the pharmacokinetics of a single intravenous dose of AZD9742 in healthy elderly volunteers
Blood and urine samples will be collected for the 4 days while in residence.
Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, telemetry)
Collected prior to treatment, during treatment, and follow-up for a maximum of 57 days for group 1 and 53 days for group 2 (this includes up to 28 days for screening).
Characterize the Pharmacokinetics of AZD9742 in blood and urine
PK-sampling during 14 pre-defined study days for PK profiling
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALSingle dose of 750mg of intravenous AZD9742 in healthy elderly volunteers
2PLACEBO_COMPARATORSterile 5% dextrose solution
AZD9742 IV InfusionEXPERIMENTALActive
Placebo to AZD9742 IV InfusionPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
AZD9742DRUGSterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL
PlaceboDRUGSterile 5% dextrose solution
DiltiazemDRUGOrally, daily beginning on Day 4 for 14 consecutive days
ketoconazoleDRUG200 mg, orally, every 12 hours starting on Day 4 for 10 consecutive days in which on Day 13 only the morning dose will be administered
Placebo to match AZD9742DRUGSingle IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female volunteers at age of 65 years or older with suitable veins for cannulation or repeated venipuncture, in good health (based on medical history and physical examination and clinical laboratory tests) as judged by the investigator. * Female volunteers must be post...

Countries:United States
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Frequently asked questions about AZD9742

What is AZD9742 used for?

AZD9742 is an investigational small molecule being studied in healthy volunteers to assess its safety, tolerability, and pharmacokinetics. It is not approved for any disease and remains in Phase 1 clinical development. Studies have evaluated single and multiple intravenous doses, including in Japanese subjects, but no therapeutic indication has been established.

Who makes AZD9742?

AZD9742 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker AZN. The company has sponsored all completed Phase 1 trials of this investigational small molecule.

What phase is AZD9742 in?

AZD9742 is in Phase 1 clinical development. All three completed trials are Phase 1 studies, and there are no active trials currently listed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AZD9742 in?

AZD9742 has completed four Phase 1 trials: NCT01030224, NCT01064388, NCT01114152, and NCT01124760. These studies evaluated single and multiple ascending doses in healthy subjects, including Japanese participants, and assessed potential drug interactions with diltiazem or ketoconazole.

Is AZD9742 the same as any other drug?

No alternative names for AZD9742 have been disclosed in the clinical trial records. The compound is identified solely by its code name AZD9742 across all completed studies.