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

Single Center, Randomized, Open-label, 5-fold Crossover Study in Healthy Male Subjects to Investigate the Pharmacokinetic Dose Proportionality of BAY94-8862 Given as 5 Different Single Oral IR Tablet Doses (1.25, 2.5, 5.0, 7.5 and 10 mg)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01687920

Enrollment

Registered

2012-09-19

Start date

2012-09-17

Completion date

2013-03-21

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiac disorders

Brief summary

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

Interventions

DRUGBAY94-8862 (1.25mg)

DRUGBAY94-8862 (2.5mg)

DRUGBAY94-8862 (5mg)

DRUGBAY94-8862 (7.5mg)

DRUGBAY94-8862 (10mg)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 46 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026