A phase I clinical trial to study the safety and tolerability of a new compound RBx 10017609 in healthy volunteers
- Registration Number
- CTRI/2008/091/000299
- Lead Sponsor
- Ranbaxy Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 76
1.Healthy males in the age range of 18 -45 years with Body Mass Index (BMI)* between 19 ? 28 kg/m2.
2.Full comprehension: 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.
3.Have voluntarily given written informed consent to participate in this study.
4.Be of normal health as determined by medical history, have sitting systolic blood pressure of ≥ 100 mmHg to < 140 mmHg and diastolic blood pressure of ≥ 60 mmHg or < 90 mmHg, pulse rate ≥60 & ≤ 90 bpm, clinical examination and laboratory investigations performed within 21 days prior to the commencement of the study.
* BMI = Body weight (in kg)/ Height (in m2)
Additional Inclusion criteria for Food effect study (Part-2).
5.Have a non-vegetarian diet habit.
1.History of hypersensitivity to any drug or history of asthma or allergic reactions/atopy
2.Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
3.Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or venereal infection.
4.Presence of values which are out of acceptable limits for haemoglobin, RBC, hematocrit, mean corpuscular haemoglobin (MCH), Mean corpuscular volume (MCV), mean corpuscular haemoglobin concentration (MCHC), bleeding time (BT), clotting time (CT), activated partial thromboplastin time (aPTT), prothrombin time (PT), total white blood cells (WBC) count, differential WBC count or platelet count.
5.Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
6.Presence of values which are out of acceptable limits for blood urea nitrogen (BUN), serum creatinine, uric acid, sodium, potassium, calcium, phosphorus, chloride, bicarbonate, alkaline phosphatase (ALP), aspartate amino transferase (AST), alanine amino transferase (ALT), total bilirubin, gamma glutamyl transferase (GGT), albumin, globulin, total protein, cholesterol, triglycerides, lactate dehydrogenase (LDH), creatinine phosphokinase (CPK), glucose (Part 1 and 2) and Cystatin C (Part 1).
7.Clinically abnormal chemical and microscopic examination of urine.
8.Clinically abnormal ECG (12 lead), QTc >440 msec and abnormal Chest X-Ray.
9.History of or any complaints suggestive of gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological (including generalized or partial epilepsy), endocrine, vision abnormality, rheumatological, urogenital or haematological disease.
10.Presence of significant infection or known inflammatory process.
11.History of joint pain, stiffness and reduced mobility.
12.Presence of acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heart burn).
13.Presence of chronic constipation (less than 3 times a week for 12 weeks) at the time of screening and/or admission.
14.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.
15.Use of tobacco in any form (including cigarette smoking) in the last 6 months.
16.History of drug dependence or habitual alcohol abuse.
17.History of intake of chronic medication.
18.Use of any regular medication (OTC or prescription) with in 14 days or any drug metabolizing enzyme modifying medications within 30 days prior to Day 1 of this study.
19.Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
20.Volunteers who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method