Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01687920
First received: September 14, 2012
Last updated: January 9, 2013
Last verified: January 2013
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Purpose
This study should estimate the dose proportionality of BAY94-8862 IR tablets.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Drug: BAY94-8862 (1.25mg) Drug: BAY94-8862 (2.5mg) Drug: BAY94-8862 (5mg) Drug: BAY94-8862 (7.5mg) Drug: BAY94-8862 (10mg) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official 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) |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862 [ Time Frame: Up to 48 h ] [ Designated as safety issue: Yes ]
| Enrollment: | 25 |
| Study Start Date: | September 2012 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BAY94-8862 (1.25mg)
single dose BAY94-8862 IR tablet 1.25mg
|
Drug: BAY94-8862 (1.25mg) |
|
Experimental: BAY94-8862 (2.5mg)
single dose BAY94-8862 IR tablet 2.5mg
|
Drug: BAY94-8862 (2.5mg) |
|
Experimental: BAY94-8862 (5mg)
single dose BAY94-8862 IR tablet 5mg
|
Drug: BAY94-8862 (5mg) |
|
Experimental: BAY94-8862 (7.5mg)
single dose BAY94-8862 IR tablet 7.5mg
|
Drug: BAY94-8862 (7.5mg) |
|
Experimental: BAY94-8862 (10mg)
single dose BAY94-8862 IR tablet 10mg
|
Drug: BAY94-8862 (10mg) |
Eligibility| Ages Eligible for Study: | 18 Years to 46 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Head of Clinical Sciences, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01687920 History of Changes |
| Other Study ID Numbers: | 15481, 2012-003055-10 |
| Study First Received: | September 14, 2012 |
| Last Updated: | January 9, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Bayer:
|
Cardiac disorders |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013