Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-31 @ 4:54 AM
Study NCT ID:
NCT01318551
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2011-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2014-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2011-03-10', 'studyFirstSubmitQcDate': '2011-03-17', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Up to 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC) of BAY85-3934', 'timeFrame': 'Day 0 to day 4'}, {'measure': 'Peak Plasma Concentration (Cmax) of BAY85-3934', 'timeFrame': 'Day 0 to day 4'}, {'measure': 'Dose-normalized area under the plasma concentration-time curve (AUCnorm) of BAY85-3934', 'timeFrame': 'Day 0 to day 4'}, {'measure': 'Dose- and body weight-normalised Cmax (Cmax-norm) of BAY85-3934', 'timeFrame': 'Day 0 to day 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anemia'], 'conditions': ['Anemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products'}]}, 'descriptionModule': {'briefSummary': 'Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The informed consent must be signed before any study-specific tests or procedures are done.\n* Female subjects with no child-bearing potential (postmenopausal women with 12 months of spontaneous amenorrhea or with 6 months of spontaneous amenorrhea and serum FSH concentrations \\>30 mIU/mL, women with 6 weeks post bilateral ovariectomy, woman with bilateral tubal ligation, and women with hysterectomy).\n* Male subjects who agree to use 2 forms of effective contraception during the study and for 12 weeks after receiving the study drug. This must include a condom with spermicide gel for 21 days after drug administration.\n* Male subjects who agree not to act as sperm donors for 12 weeks after dosing.\n* Age: ≥18 and ≤79 years at the pre-study visit.\n* Body mass index (BMI): ≥18 and ≤34 kg/m2.\n* Ethnicity: white.\n* • Subjects participating in this trial and having received 20 mg BAY 85 3934 are encouraged to participate in the following optionally 40 mg and 80 mg study parts.\n* Ability to understand and follow study-related instructions.\n* For subjects with renal impairment:\n\n * In diseased subjects: CLCR \\<90 mL/min determined from a serum creatinine control.\n * In diseased subjects: stable renal disease, ie a serum creatinine value determined at least 3 months before the pre-study visit during routine diagnostics independently of the study should not vary by more than 20% from the serum creatinine value determined at the pre-study visit.\n* For healthy subjects:\n\n * Mean age and body weight in Group 1 or Group 6 or Group 11 (control group, healthy subjects) and Groups 2 to 5 and Groups 7 to 10 and Groups 12 to 15 should not vary by more than +10 years and +10 kg, respectively..\n * In diseased subjects: CLCR ≥90 mL/min determined from a serum creatinine control.\n\nExclusion Criteria:\n\n* Participation in another clinical trial during the preceding 3 months for multiple-dose studies and 1 month for single-dose studies; (final examination from previous study to first treatment of new study).\n* Exclusion periods from other studies or simultaneous participation in other clinical studies.\n* Donation of \\>100 mL of blood within 4 weeks before the first study drug administration or \\>500 mL in the preceding 3 months.\n* Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator.\n* Severe infection or any clinically significant illness within 4 weeks prior to dosing.\n* Known hypersensitivity to the study drugs (active substances, or excipients of the preparations).\n* Known severe allergies, non-allergic drug reactions, or multiple drug allergies.\n* Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab), human immune deficiency virus antibodies (HIV 1/2 Ab).\n* Regular use of recreational drugs, eg carnitine products, anabolics.\n* Regular daily consumption of ≥ 0.5 L of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form.\n* Suspicion of drug or alcohol abuse.\n* Positive urine drug screening.\n* Regular daily consumption of \\>25 cigarettes.\n* Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety.\n* Use of medication within the 2 weeks preceding the study which could interfere with the investigational product.\n* For subjects with renal impairment:\n\n * Acute renal failure.\n * Acute nephritis.\n * Nephrotic syndrome.\n * Any organ transplant \\< 1 year before participation in this study.\n * Failure of any other major organ system other than the kidney.\n * Relevant impairment in liver function of by option of the investigator.\n * Pre-existing diseases for which it can be assumed that the absorption of the study drugs will not be normal (ie relevant malabsorption, chronic diarrhea).\n * Diastolic blood pressure (DBP) \\>100 mmHg and/or systolic blood pressure (SBP) \\>180 mmHg (at the pre-study examination; readings taken at the end of the dosing interval of antihypertensive medication, if any).\n * Heart rate \\<45 or \\>100 BPM for subject aged 18 to ≤50 years and \\<55 or \\>110 BPM for subject aged \\>50 to ≤79 years at screening visit.\n * Significant uncorrected rhythm or conduction disturbances such as a second- or third-degree AV block without a cardiac pacemaker or episodes of sustained ventricular tachycardia, or by option of the investigator.\n * Diagnosed malignancy within the past 5 years.\n * Psychiatric disorders which may disable the subjects to consent.\n * Change in chronic medications \\<4 weeks prior to dosing.\n * Concomitant use of any medication except medications necessary for the treatment of the kidney disease or related complications.\n* For healthy subjects\n\n * Subjects with conspicuous findings in medical history or pre-study examination by option of the investigator.\n * A history of relevant diseases of vital organs, of the central nervous system or other organs.\n * Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.\n * Systolic blood pressure \\<100 mmHg or \\>145 mmHg.\n * Diastolic blood pressure \\>95 mmHg.\n * Heart rate \\<45 or \\>95 BPM for subject aged 18 to ≤50 years and \\<55 or \\>95 BPM for subject aged \\>50 to ≤79 years at screening visit.\n * Clinically relevant findings in the ECG such as a second- or third-degree AV block, clinically relevant prolongation of the QRS complex \\>120 ms or of the QTc interval \\>450 ms for men and \\>470 ms for women of by option of the investigator.\n * Clinically relevant deviations of the screened laboratory parameters in clinical chemistry, hematology, or urinalysis from reference range of by option of the investigator."}, 'identificationModule': {'nctId': 'NCT01318551', 'briefTitle': 'Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Investigation of Pharmacokinetics, Safety, Tolerability, and Pharmacodynamic Effects of BAY85-3934 in Male and Female Subjects With Renal Impairment and in Age- and Weight-matched Healthy Subjects Following a Single Oral Dose of 20 mg and 40 mg (Optional) BAY 85-3934 Administered as Tablets in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification', 'orgStudyIdInfo': {'id': '15557'}, 'secondaryIdInfos': [{'id': '2011-000055-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: BAY85-3934']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: BAY85-3934']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'interventionNames': ['Drug: BAY85-3934']}], 'interventions': [{'name': 'BAY85-3934', 'type': 'DRUG', 'description': 'single dose, 20 mg', 'armGroupLabels': ['Arm 1']}, {'name': 'BAY85-3934', 'type': 'DRUG', 'description': 'single dose, 40 mg (optional)', 'armGroupLabels': ['Arm 2']}, {'name': 'BAY85-3934', 'type': 'DRUG', 'description': 'single dose, 80 mg (optional)', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24105', 'city': 'Kiel', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}