A Study of RBx 10017609 in Elderly Male and Female Subjects
Scientific Title of Study
A Single-Blind, Randomized, Placebo Controlled, Single Dose Safety, Tolerability and Pharmacokinetic Study of
RBx 10017609 in Elderly Male and Female Subjects
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
101_17609_09
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr. Monika Tandon
Designation
Affiliation
Address
Ranbaxy Laboratories Limited B-22, Sector 62 Not Applicable N/A
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.
ExclusionCriteria
Details
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 140 mmHg or diastolic blood pressure <50 mmHg or ≥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).
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
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.
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.
Others: Urine microprotiens-Retinol binding protein (RBP), N-acetyl-ß-D-Glucosaminidase (NAG) and microalbumin (corrected for urine creatinine) measurement.
Urinary pregnancy tests for females will be carried out at screening, prior to admission and at discharge.
Serological tests: HbsAg, HCV antibody, HIV I & II and VDRL
Drugs of abuse, cotinine assay and alcohol screen: Drugs of abuse (opiates or cannabinoids), cotinine assay in urine and breath test for alcohol will be performed at the time of screening and admission.
Hematology, biochemistry and urinalysis will be performed at screening, admission, 24 and 72 hrs post-dose. Further the laboratory investigations will be done at the discretion of investigator. The frequency of the investigation may be modified as decided by the investigator. Viral serology will be performed at screening only.
Secondary Outcome
Outcome
TimePoints
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.
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.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a single-blind, randomized, placebo controlled, single dose safety, tolerability and pharmacokinetic study of RBx 10017609 in elderly male and female subjects. the dose to be investigated in the study is 400 mg.