None listed
Conditions
Interventions
Intervention1: RBx 10017609: 400 mg oral single dose
Control Intervention1: placebo: 400 mg oral single dose
Sponsors
Ranbaxy Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Elderly male and female subjects (post menopausal) > 65 years of age with a BMI* in the range of 18-29 kg/m2, inclusive. * BMI = Body weight (in kg)/ Height (in m2) 2. Medical history, physical examination, vital signs, clinical laboratory tests and 12-lead ECG without significant abnormalities in the opinion of the investigator. 3. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study. 4. Willingness to give written informed consent (prior to any study related procedure being performed) and ability to adhere to the study restrictions and assessment schedule. 5. Negative urinary drugs of abuse test, alcohol breath test and cotinine urine test (at screening and admission day). 6. For Postmenopausal women 1. Last menstrual period (LMP) equal to or more than 1 year or surgical hysterectomy. 2. Endocrine status matching post menopausal women as confirmed by Serum FSH levels or ultrasound only in doubtful cases.
Exclusion criteria
Exclusion criteria: 1. Any known history of hypersensitivity. 2. Any evidence of organ dysfunction or any clinically relevant abnormal physical finding at the screening assessment. 3. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or venereal infection. 4. Clinically significant abnormalities in the results of the clinical laboratory tests (at screening). 5. Positive for urinary drugs of abuse test, alcohol breath test and cotinine urine test (at screening and at admission). 6. Systolic blood pressure <90 mmHg or &#61619;140 mmHg or diastolic blood pressure <50 mmHg or &#8805;90 mmHg or pulse rate <45 bpm or >100 bpm, or postural drop in blood pressure from supine to standing of >20 mmHg (systolic) or >10 mmHg (diastolic) at screening. 7. Clinical relevant abnormalities in 12-lead ECG including QTc >440 msec, and abnormal chest X-Ray. 8. History of or any complaints suggestive of clinically significant gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological (including generalized or partial epilepsy), endocrine, significant visual impairment, rheumatological, urogenital or haematological disease. 9. Presence of significant infection or known inflammatory process. 10. History of joint pain or stiffness or other causes leading to significant immobility. 11. Presence of any surgical or medical condition which in the judgement of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the study drug or might be likely to compromise the safety of the subject. 12. Inability to communicate well with investigator (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide written informed consent. 13. Use of tobacco in any form (including cigarette smoking) in the last 6 months. 14. History of drug dependence or habitual alcohol abuse. 15. History of chronic intake of medication. 16. Intake of any medication (OTC or prescription) within 14 days or any drug metabolizing enzyme modifying medications within 30 days prior to Day 1 of this study. 17. Participation in any clinical trial within 12 weeks preceding Day 1 of this study. 18. Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in last 3 months. 19. Positive urine pregnancy test at the time of screening (for females only).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability: assessed on the basis of adverse events (AEs), clinical examination, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), 12-lead ECG and clinical laboratory tests.Timepoint: Safety and Tolerability Assessments Clinical examination: Medical history and clinical examination will be performed at screening (including gynecological examination for females), admission, pre-dose, approximately every 12 hours post-dose until discharge and at follow-up. Adverse events: adverse event monitoring and recording at admission, pre-dose, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hrs post-dose, and at follow-up. Vital signs: blood pressure*, pulse rate*, respiratory rate and oral temperature will be measured and recorded at screening, at admission, pre-dose, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hrs post-dose, at follow-up and whenever Principal Investigator feels necessary. *Additionally blood pressure and pulse rate would be measured in supine and standing position at screening. ECG: 12-lead ECG will be recorded at screening, pre-dose, 2, 4, 8, 12, 24 and 72 hrs post-dose and follow-up. Continuous lead II ECG for first six hours post-dose on dosing day. Clinical laboratory tests: Haematology: Full blood count to include, haemoglobin, hematocrit, coagulation profile (PT, aPTT) red blood cell count, white blood cell count, differential white blood cell count and platelet count. Biochemistry: Blood urea nitrogen, creatinine, uric acid, sodium, potassium, calcium, alkaline phosphatase (ALP), aspartate amino transferase (AST), alanine amino transferase (ALT), total bilirubin, lactate dehydrogenase (LDH), gamma glutamyl transpeptidase (GGT), creatine phosphokinase (CPK), albumin, globulin, total protein, cholesterol, triglycerides, glucose, C-reactive protein and Cystatin C. Urinalysis: Colour, appearance, pH, specific gravity, protein, glucose, ketones, bilirubin, urobilinogen, RBC, WBC, epithelial cells, crystals, casts. Oth | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the pharmacokinetics of RBx 10017609 in elderly male and female subjects. To determine the gender related differences in pharmacokinetics and tolerance in elderly subjects. Timepoint: Blood sampling: blood samples will be collected at pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose for the estimation of RBx 10017609 and its metabolite. Urine sampling: urine sampling will be collected at pre-dose and pooled for 0-4, 4-8, 8-12, 12-24 and 24-48 hrs post-dose. | — |
Countries
India
Contacts
Public ContactDr. Vikas Modgill
Outcome results
None listed