Trial · NCT02865538
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 55
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. |
| Primary | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Time of occurrence of Cmax.Time to reach maximum plasma concentration of BAY3427080 was presented. Blood samples for Tmax were taken within 30 minutes prior to dose administration. |
| Primary | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080 | Day 1 (pre-dose and post-dose (0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 12.0 and 24.0 hours) | AUC from time zero extrapolated to infinity of BAY3427080 was presented. AUC0-∞ was only estimated following the Day 1 dose. |
| Primary | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Area under the concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration of BAY3427080 was presented. Blood samples for (AUC0-τ) were taken within 30 minutes prior to dose administration. |
| Primary | Terminal Elimination Half-life (t½) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Terminal elimination half-life of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. |
| Primary | Apparent Clearance (CL/F) of BAY3427080 | On Day 1, Day 7 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0 hours) and on Day 14 (Pre-dose; 0.5; 1.0; 1.5; 2.0; 2.5; 3.0; 4.0; 5.0; 6.0; 8.0; 12.0; 24.0, 48.0, 72.0 hours) | Apparent clearance of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration. |
| Primary | Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination. | At day 14 | A physician or appropriately qualified delegate conducted a full physical examination. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant). |
| Primary | Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs | At day 14 | Reported results are cardiovascular system-examination findings at day 14. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant). |
| Primary | Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring. | Baseline (day -1) and day 14 | Holter monitors were supplied by iCardiac Technologies. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14 and remained in place until 24-hour assessments were completed. |
| Primary | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing) | Baseline and day 14 | Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position. |
| Primary | Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting) | Baseline and day 14 | Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position. |
| Primary | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing) | Baseline and day 14 | Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position. |
| Primary | Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting) | Baseline and day 14 | Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position. |
| Primary | Change From Baseline at Day 14 in Vital Signs: Pulse Rate | Baseline and day 14 | Pulse rate was measured just prior to dosing (approx. 30 mins). |
| Primary | Change From Baseline at Day 14 in Vital Signs: Respiratory Rate | Baseline and day 14 | Respiratory rate was measured just prior to dosing (approx. 30 mins). |
| Primary | Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation | Baseline and day 14 | Oxygen Saturation was measured just prior to dosing (approx. 30 mins). |
| Primary | Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature | Baseline and day 14 | Temperature was measured just prior to dosing (approx. 30 mins). |
| Primary | Change From Baseline at Day 14 in Vital Signs: Weight | Baseline and day 14 | Weight was measured just prior to dosing (approx. 30 mins). |
| Primary | Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol. | Baseline and day 15 | Blood samples for the assessment of ACTH and Estradiol were collected upon participants admission to the unit. |
| Primary | Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone | Baseline and day 15 | Blood samples for the assessment of Follicle Stimulating were collected upon participants admission to the unit. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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