Clinical Trial Results:
A single blind, placebo controlled pilot study to explore the safety and tolerability of a single oral dose of 30 mg BAY1067197 in patients with chronic heart failure on the background of
preexisting beta-blocker therapy
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Summary
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EudraCT number |
2013-001287-34 |
Trial protocol |
NL |
Global end of trial date |
17 Mar 2015
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Results information
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Results version number |
v2 |
This version publication date |
07 Sep 2016
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First version publication date |
27 Mar 2016
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Other versions |
v1 , v3 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BAY1067197/16718
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01945606 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Bayer AG
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Sponsor organisation address |
Kaiser-Wilhelm-Allee, D-51368, Leverkusen, Germany,
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Public contact |
Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
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Scientific contact |
Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 Mar 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Mar 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The objective of this pilot study was to investigate the safety, tolerability and pharmacodynamic interaction of a single dose administration of 30 milligram (mg) BAY1067197 with selected beta-blockers in subjects with stable chronic systolic heart failure under evidence based standard therapy including selected beta-blockers.
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all subjects and/or their legally authorized representative. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
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Background therapy |
Subjects on stable standard therapy including pre-existing (for a minimum of 4 weeks) beta-blocker therapy. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Nov 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 11
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Worldwide total number of subjects |
11
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EEA total number of subjects |
11
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
7
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
Study was conducted at one study center in Netherlands, between 29 November 2013 (first subject first visit) and 09 September 2014 (last subject last visit). | ||||||
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Pre-assignment
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Screening details |
Overall 14 subjects were screened, of them, 3 were screen failure and 11 were assigned to treatment. | ||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Single blind | ||||||
Roles blinded |
Subject | ||||||
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Arms
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Arm title
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Placebo then BAY1067197 | ||||||
Arm description |
Subjects received single oral dose of placebo matched to BAY1067197 with selected standard betablocker therapy in fasted condition (treatment 1), and then followed by a single oral dose of 30 mg BAY1067197 tablet with selected standard betablocker therapy (either greater than or equal to [>=] 95 mg metoprolol succinate controlled release tablet, >=5 mg bisoprolol immediate release [IR] tablet or >=5 mg nebivolol IR tablet) in fasted condition (treatment 2). | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received single oral dose of placebo matched to BAY1067197 tablet on Day -1 in fasted condition.
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Investigational medicinal product name |
BAY1067197
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Investigational medicinal product code |
BAY1067197
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received single oral dose of 30mg BAY1067197 tablet on Day 0 in fasted condition.
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Investigational medicinal product name |
Beta-blockers
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received beta-blocker therapy with either >= 95mg metoprolol succinate (controlled release tablet) or >= 5mg bisoprolol (IR tablet) or >= 5mg nebivolol (IR tablet) with 30 mg BAY1067197 in treatment 2 and with placebo in treatment 1.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
Subjects received single oral dose of placebo matched to BAY1067197 with selected standard beta blocker therapy in fasted condition (treatment 1), and then followed by a single oral dose of 30 milligram (mg) BAY1067197 tablet with selected standard beta blocker therapy (either greater than or equal to [>=] 95 mg metoprolol succinate controlled release tablet, >=5 mg bisoprolol immediate release [IR] tablet or >=5 mg nebivolol IR tablet) in fasted condition (treatment 2). | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo then BAY1067197
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Reporting group description |
Subjects received single oral dose of placebo matched to BAY1067197 with selected standard betablocker therapy in fasted condition (treatment 1), and then followed by a single oral dose of 30 mg BAY1067197 tablet with selected standard betablocker therapy (either greater than or equal to [>=] 95 mg metoprolol succinate controlled release tablet, >=5 mg bisoprolol immediate release [IR] tablet or >=5 mg nebivolol IR tablet) in fasted condition (treatment 2). | ||
Subject analysis set title |
Safety analysis set (SAF)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
SAF (N=11) included all subjects who received at least one dose of the study medication.
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Subject analysis set title |
Pharmacodynamics (PD) analysis set (PDS)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
PDS (N=11) included all subjects who completed the study without major changes versus protocol.
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Subject analysis set title |
Pharmacokinetics (PK) analysis set (PKS)
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
PKS (N=11) included all subjects who completed the study without major changes versus protocol.
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Subject analysis set title |
Placebo + Beta-blocker
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subject received a single oral dose of placebo matched to BAY1067197 under fasted condition (treatment 1) along with selected standard beta-blocker therapy (either >=95 mg metoprolol succinate controlled release tablet, >=5 mg bisoprolol IR tablet or >=5 mg nebivolol IR tablet).
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Subject analysis set title |
BAY1067197 30 mg + Beta-blocker
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects received a single oral dose of 30 mg (3 X 10 mg) BAY1067197 tablet under fasted condition (treatment 2) along with selected standard beta-blocker therapy (either >=95 mg metoprolol succinate controlled release tablet, >=5 mg bisoprolol IR tablet or >=5 mg nebivolol IR tablet)
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End point title |
Number of Subjects With Atrio-Ventricular (AV)-Block Greater than (>) one Degree (1^0) Under Therapy With BAY1067197 and Pre-existing Beta-blocker Therapy [1] | |||||||||
End point description |
A complete standard 12-lead ECG was recorded and evaluated parameters such as heart rate, PR/PQ interval, QRSD interval, QT interval (uncorrected). ECG finding AV block >1^0 were recorded and reported.
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End point type |
Primary
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End point timeframe |
From start of study drug administration until last follow-up (Day 22)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [2] - SAF [3] - SAF |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Number of Subjects With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs) [4] | |||||||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; and another medically important serious event as judged by the investigator. Treatment-emergent were events between administration of study drug and up to Day 22 that were absent before treatment or that worsened relative to pre-treatment state.
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End point type |
Primary
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End point timeframe |
From start of study drug administration until last follow-up (Day 22)
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [5] - SAF [6] - SAF |
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Number of Subjects With Abnormal Laboratory Findings Reported as Treatment-emergent Adverse Events [7] | |||||||||
End point description |
Clinical laboratory examinations included hematology, clotting status, serum chemistry, virology, vasoactive hormones, bioanalytics and urinalysis. Abnormal laboratory parameters were reported as treatment-emergent adverse events. Treatment-emergent were events between administration of study drug and up to Day 22 that were absent before treatment or that worsened relative to pre-treatment state.
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End point type |
Primary
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End point timeframe |
From start of study drug administration until last follow-up (Day 22)
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [8] - SAF [9] - SAF |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Change From Baseline in Heart Rate at Specified Time Point [10] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Heart rate after resting in supine position for at least 30 minute was recorded and analysed. In the below table, "n" signifies subjects who were evaluable for the specified parameter for each arm, respectively. '99999' in the below table indicates that the data were not analysed for a respective reporting at specified time-points.
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End point type |
Primary
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End point timeframe |
From start of study drug administration until last follow-up (Day 22)
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: EudraCT database does auto-addition of number of subjects analysed while reporting an explorative analysis of two treatment groups. Due to this format constraint, charts have been uploaded with the accurate details of statistical analyses for this endpoint. Please find the statistical analyses in the attachment below. |
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Attachments |
Statistical Analysis_Heart rate |
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| Notes [11] - SAF [12] - SAF |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Abnormal Clinically Significant Electrocardiogram (ECG) Findings [13] | |||||||||
End point description |
A complete standard 12-lead ECG was recorded and evaluated parameters such as heart rate, PR/PQ interval, QRSD interval, QT interval (uncorrected). Criteria for abnormal clinically significant findings in the ECG were such as a second or third degree atrio-ventricular (AV) block. The changes in the above parameters were considered as "clinically significant" at the discretion of the investigator.
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End point type |
Primary
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End point timeframe |
From start of study drug administration until last follow-up (Day 22)
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| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics were done, no inferential statistical analyses were performed. |
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| Notes [14] - SAF [15] - SAF |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Change From Baseline in Blood Pressure at Specified Time Point [16] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Blood pressure measured by central bedside monitoring system to record subject’s Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and mean arterial blood pressure (MAP). In the below table, "n" signifies subjects who were evaluable for the specified parameter for each arm, respectively. '99999' in the below table indicates that the data were not analysed for a respective reporting group at specified time-points.
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End point type |
Primary
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End point timeframe |
From start of study drug administration until last follow-up (Day 22)
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| Notes [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: EudraCT database does auto-addition of number of subjects analysed while reporting an explorative analysis of two treatment groups. Due to this format constraint, charts have been uploaded with the accurate details of statistical analyses for this endpoint. Please find the statistical analyses in the attachment below. |
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Attachments |
Statistical Analysis_Blood pressure |
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| Notes [17] - SAF [18] - SAF |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of BAY84-3174 in Plasma After Single Dose of BAY1067197 | ||||||||
End point description |
Area under the concentration versus time curve from zero to infinity after single dose. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
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End point type |
Secondary
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End point timeframe |
Pre-dose; 0 (0.5, 1, 2, 3, 4, 6 and 12 hours), 1, 2, 5, 13 and 21 days post-dose
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| Notes [19] - PKS |
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| No statistical analyses for this end point | |||||||||
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End point title |
AUC of BAY84-3174 from Time 0 to the Last Data Point Greater than (>) Lower Limit of Quantification (AUC[0-last]) After Single Dose of BAY1067197 | ||||||||
End point description |
AUC from time 0 to the last data point >lower limit of quantification, calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
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End point type |
Secondary
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End point timeframe |
Pre-dose; 0 (0.5, 1, 2, 3, 4, 6 and 12 hours), 1, 2, 5, 13 and 21 days post-dose
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| Notes [20] - PKS |
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| No statistical analyses for this end point | |||||||||
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End point title |
Maximum Observed BAY84-3174 Concentration in Plasma (Cmax) After Single Dose of BAY1067197 | ||||||||
End point description |
Maximum observed BAY84-3174 concentration in plasma, directly taken from analytical data. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
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End point type |
Secondary
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End point timeframe |
Pre-dose; 0 (0.5, 1, 2, 3, 4, 6 and 12 hours), 1, 2, 5, 13 and 21 days post-dose
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| Notes [21] - PKS |
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| No statistical analyses for this end point | |||||||||
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End point title |
Half-Life (t1/2) Associated With the Terminal Slope of BAY84-3174 After Single Dose of BAY1067197 | ||||||||
End point description |
Half-life associated with the terminal slope. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
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End point type |
Secondary
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End point timeframe |
Pre-dose; 0 (0.5, 1, 2, 3, 4, 6 and 12 hours), 1, 2, 5, 13 and 21 days post-dose
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| Notes [22] - PKS |
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| No statistical analyses for this end point | |||||||||
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End point title |
Apparent Oral Clearance (CL/F) of BAY84-3174 After Single Dose of BAY1067197 | ||||||||
End point description |
Total body clearance of drug calculated after extra-vascular application.
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End point type |
Secondary
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End point timeframe |
Pre-dose; 0 (0.5, 1, 2, 3, 4, 6 and 12 hours), 1, 2, 5, 13 and 21 days post-dose
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| Notes [23] - PKS |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to Reach Maximum BAY84-3174 Concentration (tmax) in Plasma After Single Dose of BAY1067197 | ||||||||
End point description |
Time to reach maximum drug concentration in the measured matrix, directly taken from analytical data.
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End point type |
Secondary
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End point timeframe |
Pre-dose; 0 (0.5, 1, 2, 3, 4, 6 and 12 hours), 1, 2, 5, 13 and 21 days post-dose
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| Notes [24] - PKS |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From start of study drug administration until last follow-up (Day 22)
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
BAY1067197 30 mg + Beta-blocker
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Reporting group description |
Subjects received a single oral dose of 30 mg (3 X 10 mg) BAY1067197 tablet under fasted condition (treatment 2) along with selected standard beta-blocker therapy(either >=95 mg metoprolol succinate controlled release tablet, >=5 mg bisoprolol IR tablet or >=5 mg nebivolol IR tablet). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo + Beta-blocker
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Reporting group description |
Subject received a single oral dose of placebo under fasted condition (treatment 1) along with selected standard beta-blocker therapy (either >=95 mg metoprolol succinate controlled release tablet, >=5 mg bisoprolol IR tablet or >=5 mg nebivolol IR tablet). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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08 Oct 2013 |
1. Status of the study was changed to pilot study 2. Deletion of leucine aminopeptidase as a laboratory parameter 3. Adverse events of special interest section was updated 4. Minor corrections to the protocol text. |
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19 Nov 2013 |
1. Exclusion of women of childbearing potential 2. Deletion of serum beta-human chorionic gonadotropin pregnancy test 3. Minor corrections to the protocol text. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Occurrence of "±” in relation with geometric CV is auto-generated and cannot be deleted. Decimal places were automatically truncated if last decimal equals zero. | |||
