Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets

Phase 1

Completed

• Conditions: Heart Failure
• Interventions: Drug: BAY94-8862 (1.25mg); Drug: BAY94-8862 (2.5mg); Drug: BAY94-8862 (5mg); Drug: BAY94-8862 (7.5mg); Drug: BAY94-8862 (10mg)

• Registration Number: NCT01687920
• Lead Sponsor: Bayer

Brief Summary

This study should estimate the dose proportionality of BAY94-8862 IR tablets.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-14
• Study First Submitted QC: 2012-09-14
• Study Start: 2012-09-17
• Study First Posted: 2012-09-19
• Primary Completion: 2012-11-28
• Study Completion: 2013-03-21
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Healthy male subject
• Age: 18 to 46 years (inclusive) at the first screening examination
• Ethnicity: White
• Body mass index (BMI): >= 18 and <= 29.9 kg / m²

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Exclusion Criteria

• Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec
• Systolic blood pressure below 100 or above 140 mmHg
• Diastolic blood pressure below 50 or above 90 mmHg
• Heart rate below 50 or above 95 beats/ min
• Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
• Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BAY94-8862 (1.25mg)	BAY94-8862 (1.25mg)	single dose BAY94-8862 IR tablet 1.25mg
BAY94-8862 (2.5mg)	BAY94-8862 (2.5mg)	single dose BAY94-8862 IR tablet 2.5mg
BAY94-8862 (5mg)	BAY94-8862 (5mg)	single dose BAY94-8862 IR tablet 5mg
BAY94-8862 (7.5mg)	BAY94-8862 (7.5mg)	single dose BAY94-8862 IR tablet 7.5mg
BAY94-8862 (10mg)	BAY94-8862 (10mg)	single dose BAY94-8862 IR tablet 10mg

Primary Outcome Measures

Name	Time	Method
Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets	0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862	Up to 48 h

Trial Locations

Locations (1)

CRS Clinical-Research-Services Mönchengladbach GmbH; 🇩🇪 Mönchengladbach, Nordrhein-Westfalen, Germany