| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04076540 | A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4041 in Healthy Volunteers | PHASE1 | COMPLETED | 48 | — | — | Oct 3, 2019 | Jan 2, 2022 | Jul 17, 2024 | 2 | United States |
Number of participants experiencing any adverse event
Number of participants experiencing any treatment emergent adverse events
Number of participants experiencing any treatment-related TEAEs
Number of participants experiencing any moderate TEAEs
Number of participants experiencing any treatment-related moderate TEAEs
Number of participants experiencing any severe TEAEs
Number of participants experiencing any treatment-related severe TEAEs
Number of participants experiencing any serious adverse events (SAEs)
Number of participants experiencing any treatment-related serious adverse events (SAEs)
Number of participants with treatment-emergent adverse events leading to early discontinuation
Number of participants who died
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 treatment-related abnormal blood pressure considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Number of participants with treatment-related abnormal heart rate considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured by standing pulse rate at baseline and 2 hours post
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 treatment-related abnormal serum chemistry values considered clinically significant or reported as a treatment-emergent adverse event by the investigator
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 electrocardiograms (ECGs), considered clinically significant or reported as a treatment-emergent adverse event by the investigator
Measured by digital electrocardiograms (ECGs)
PR interval is the time from the beginning of atrial depolarization to the onset of ventricular depolarization. Measured by digital electrocardiograms (ECGs)
QRS complex represents the electrical impulse as it spreads through the ventricles and indicates ventricular depolarization. Measured by digital electrocardiograms (ECGs)
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)
The QTcF if the QT interval corrected for heart rate using Fridercia's formula. Measured by digital electrocardiograms (ECGs)
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 levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
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 (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 levels test results, considered clinically significant or reported as a treatment-emergent adverse event by the investigator
| Arm | Type | Description |
|---|---|---|
| AZD4041 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AZD4041 | DRUG | Administration by Oral syringe |
| Placebo | DRUG | Administration by Oral syringe |
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...