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Completed

NCT Number: NCT01687920

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–46 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BAY94-8862 (1.25mg)

Drug

BAY94-8862 (2.5mg)

Drug

BAY94-8862 (5mg)

Drug

BAY94-8862 (7.5mg)

Drug

BAY94-8862 (10mg)

Drug

Primary outcomes

  1. Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets

    Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h

Secondary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862

    Time frame: Up to 48 h

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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)

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Sep 19, 2012
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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