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

Bayer

Status and phase: Completed; Phase 1

Conditions: Heart Failure

Treatments: Drug: BAY94-8862 (7.5mg); Drug: BAY94-8862 (2.5mg); Drug: BAY94-8862 (10mg); Drug: BAY94-8862 (1.25mg); Drug: BAY94-8862 (5mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01687920

15481

2012-003055-10 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: Male

Ages: 18 to 46 years old

Volunteers: Accepts Healthy Volunteers

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

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 5 patient groups

BAY94-8862 (1.25mg)

Experimental group

Description:

single dose BAY94-8862 IR tablet 1.25mg

Treatment:

Drug: BAY94-8862 (1.25mg)

BAY94-8862 (2.5mg)

Experimental group

Description:

single dose BAY94-8862 IR tablet 2.5mg

Treatment:

Drug: BAY94-8862 (2.5mg)

BAY94-8862 (5mg)

Experimental group

Description:

single dose BAY94-8862 IR tablet 5mg

Treatment:

Drug: BAY94-8862 (5mg)

BAY94-8862 (7.5mg)

Experimental group

Description:

single dose BAY94-8862 IR tablet 7.5mg

Treatment:

Drug: BAY94-8862 (7.5mg)

BAY94-8862 (10mg)

Experimental group

Description:

single dose BAY94-8862 IR tablet 10mg

Treatment:

Drug: BAY94-8862 (10mg)