None listed
Conditions
Interventions
Intervention1: ZYPH0907: 1. Route of administrration: Oral
2. Dosage:0.025mg,
3. Frequency:
Plan I(a single ascending dose study),II(a single dose food effect study) and III(a single dose in female)
Sponsors
Zydus Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy Male or female between 30 and 55 years of age 2.A female subject is eligible to participate if she is of non-childbearing potential 3.Male subjects must agree to use one of the contraception methods 4.BMI within the range 20 - 29.9 kg per m2 5.Capable of giving written informed consent, which includes compliance with protocol 6.QTcB or QTcF less than 450msec. In case of post menopausal women, 1.Postmenopausal women diagnosed as osteoporosis with T score between ranges of -1 to -4 at any one of the two sites measured (lumbar spine and femoral neck). 2.Subjects who are in the opinion of the investigator, likely to comply with the protocol and the investigatorâ??s instructions during the study period. 3.Subjects giving informed consent for participation in the study. 4. Subjects who are taking low-dose aspirin for cardiovascular prophylaxis (81mg or less) are eligible to participate in the study, but the aspirin must be discontinued from Screening to the Follow-up visit
Exclusion criteria
Exclusion criteria: 1.Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYPH0907 formulation 2.History of nephrolithiasis/ urolithiasis in the past 1 year. 3.Abnormal liver function test (ALT/AST more than or equal to 2.5 times UNL) or kidney function test (serum creatinine more than or equal to 2.0 mg/dl and calculated GFR value). 4.Abnormal laboratory values of parathyroid hormone (PTH), Serum Calcium (Ca),and Alkaline phosphatase (ALP). 5.History of hyperuricemia/gout. 6.History of diseases causing malabsorption in the last one year. 7.Subjects with abnormal ECG findings. 8.The subject has a positive pre-study drug/alcohol screen 9.Positive urinary cotinine levels or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening. 10.History of regular alcohol consumption within 6 months of the study 11.History of sensitivity to heparin or heparin-induced thrombocytopenia 12.Unable or unwilling to abstain from caffeine-or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment at each treatment level. 13.History or presence of significant drug abuse 14.Use of alcohol for 24 hours prior to dosing until final post-dose assessment at each treatment level. 15.A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening 16.A positive test for HIV antibody 17.Pregnant females as determined by positive urine hCG test at screening or prior to dosing 18.Lactating females 19.Has anemia defined by hemoglobin concentration 11.0g/dL for males or less than 10.0g/dL for females. 20.Abnormal vital signs 21.History of any gastrointestinal or hepatic conditions that could impact absorption of the investigational compound. 22.Family history of torsade de pointes or other ventricular arrhythmias. 23.Family history of unexplained sudden death. 24.Subjects who have asthma or a history of asthma 25.Exposure to more than four new chemical entities within 12 months prior to the first dosing day 26.Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days or 14 days if the drug is a potential enzyme inducer or 5 half-lives prior to the first dose of study medication, unless in the opinion of the Investigator and CHL Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. 27.Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period 28.Unwillingness or inability to follow the procedures outlined in the protocol. 29.As a result of the medical interview, physical examination, or screening investigations, the investigator considers the subject unfit for the study. 30.Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability Timepoint: Safety and tolerability Plans I,II and III[upto Day 8] Plan IV [ upto Day 21 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics and pharmacokineticsTimepoint: PK: 1.Blood â?¢Plans I, II, III: [Time frame: pre dose to 72 hrs post Dose on Day 8] â?¢Plan IV: [Pre-dose to 72 hrs post dose on Day 14] 2. Urine: â?¢Plans I, II, III: [Time frame: pre dose to 48 hrs post Dose Day 3] â?¢Plan IV: [Pre-dose to 48 hrs of first dosing on Day 14] PD: â?¢Plan IV [Time frame: Blood and urine sampling on day 1,7 and 14] | — |
Countries
India
Contacts
Public ContactDr R H Jani
Zydus Research Centre
Outcome results
None listed