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AZD4041

Phase 1

Smoking Cessation | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 17, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04076540A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4041 in Healthy VolunteersPHASE1 COMPLETED 48Oct 3, 2019Jan 2, 2022Jul 17, 20242 United States
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Study Endpoints
Primary Endpoints
Number of Adverse Events
6 weeks

Number of participants experiencing any adverse event

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
6 weeks

Number of participants experiencing any treatment emergent adverse events

Number of Participants With Treatment-Related TEAEs
6 weeks

Number of participants experiencing any treatment-related TEAEs

Number of Participants With Moderate TEAEs
6 weeks

Number of participants experiencing any moderate TEAEs

Number of Participants With Treatment-Related Moderate TEAEs
6 weeks

Number of participants experiencing any treatment-related moderate TEAEs

Number of Participants With Severe TEAEs
6 weeks

Number of participants experiencing any severe TEAEs

Number of Participants With Treatment-Related Severe TEAEs
6 weeks

Number of participants experiencing any treatment-related severe TEAEs

Number of Participants With Serious Adverse Events (SAEs)
6 weeks

Number of participants experiencing any serious adverse events (SAEs)

Number of Participants With Treatment-Related SAEs
6 weeks

Number of participants experiencing any treatment-related serious adverse events (SAEs)

Number of Participants With TEAEs Leading to Early Discontinuation
6 weeks

Number of participants with treatment-emergent adverse events leading to early discontinuation

Number of Participant Deaths
6 weeks

Number of participants who died

Number of Participants With Abnormal Vital Signs
6 weeks

Number of participants with treatment-related abnormal vital signs considered clinically significant or reported as a treatment-emergent adverse event by the investigator.

Number of Participants With Abnormal Vital Signs (Blood Pressure)
6 weeks

Number of participants with treatment-related abnormal blood pressure considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal Vital Signs (Heart Rate)
6 weeks

Number of participants with treatment-related abnormal heart rate considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Pulse Rate at Baseline and Day 1 2 Hours Post.
Baseline and Day 1

Measured by standing pulse rate at baseline and 2 hours post

Number of Participants With Abnormal Safety Laboratory Tests (Hematology)
6 weeks

Number of participants with treatment-related abnormal hematology values considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal Safety Laboratory Tests (Serum Chemistry)
6 weeks

Number of participants with treatment-related abnormal serum chemistry values considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal Safety Laboratory Tests (Urinalysis)
6 weeks

Number of participants with treatment-related abnormal urinalysis values considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal 12-lead ECGs
4 days

Number of participants with abnormal 12-lead electrocardiograms (ECGs), considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Heart Rate at Baseline and Times Post Dose
Thru Day 4

Measured by digital electrocardiograms (ECGs)

Aggregate P-R Interval at Baseline and Time Post Dose
Thru Day 4

PR interval is the time from the beginning of atrial depolarization to the onset of ventricular depolarization. Measured by digital electrocardiograms (ECGs)

Aggregate QRS Complex at Baseline and Times Post Dose
Thru Day 4

QRS complex represents the electrical impulse as it spreads through the ventricles and indicates ventricular depolarization. Measured by digital electrocardiograms (ECGs)

Aggregate QT Interval at Baseline and Times Post Dose
Thru Day 4

The QT interval is measured from the beginning of the QRS complex to the end of the T wave and primarily represents the return of stimulated ventricles to their resting state (ventricular repolarization). Measured by digital electrocardiograms (ECGs)

Aggregate QTcF Interval and Times Post Dose
Thru Day 4

The QTcF if the QT interval corrected for heart rate using Fridercia's formula. Measured by digital electrocardiograms (ECGs)

Aggregate RR Interval at Baseline and Times Post Dose
Thru Day 4

The RR interval the time elapsed between two successive R waves of the QRS signal on the electrocardiogram. Measured by digital electrocardiograms (ECGs)

Number of Participants With Abnormal Testosterone Test Results
Thru Day 4

Number of participants with abnormal testosterone levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal Luteinizing Hormone Test Results
Thru Day 4

Number of participants with abnormal luteinizing hormone (LH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal Follicle Stimulating Hormone Test Results
Thru Day 4

Number of participants with abnormal follicle stimulating hormone (FSH) levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Number of Participants With Abnormal Inhibin B Test Results
Thru Day 4

Number of participants with abnormal Inhibin B levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator

Secondary Endpoints
Cmax of AZD4041
Thru Day 4
Tmax of AZD4041
Thru Day 4
AUC0-t
Thru Day 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD4041EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AZD4041DRUGAdministration by Oral syringe
PlaceboDRUGAdministration by Oral syringe
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion criteria 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in this clinical study protocol. 2. Provision of signed and dated, written Informed Consent Form prior to any mandatory study spe...

Countries:United States
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