None listed
Conditions
Interventions
Intervention1: ZY19489 Capsule: 1)Route of Administration:Oral 2.Frequency: Multiple dose 3)Dose :- as per Cohort. 4) Duration : Baseline to End of study
Control Intervention1: Placebo: 1)Route of Ad
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female (non-pregnant, non-lactating) aged 18 to 55 years inclusive who will be contactable and available for the duration of the trial and up to 2 weeks following the End of Study visit. 2. Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18.5 to 30.0 kg/m2 (Both inclusive) . BMI is an estimate of body weight adjusted for height. It is calculated by dividing the weight in kilograms by the square of the height in meters. 3. Certified as healthy by a comprehensive clinical assessment (detailed medical history, complete physical examination and special investigations). 4. Screening vital signs: Systolic blood pressure (SBP) - 90-140 mmHg, Diastolic blood pressure (DBP) - 60-90 mmHg, Heart rate (HR) 60-90 bpm. 5. QTcF �450 ms, PR interval �220 ms. 6. Female subjects with history of sterility or at least 1 year menopause or use of long acting non hormonal contraceptive measures (e.g., intrauterine device) and be willing and able to continue contraception for 90 days after administration of study treatment.. 7. Male subjects must agree to use adequate contraception methods during the study and be willing and able to continue contraception for 90 days after administration of study treatment. 8. Completion of the written informed consent process prior to undertaking any study related procedure. 9. Must be willing and able to communicate and participate in the whole study.
Exclusion criteria
Exclusion criteria: 1. Haematology, clinical chemistry or urinalysis results at screening that are outside of clinically acceptable laboratory ranges, and are considered clinically significant by the Investigator. 2. Participation in any investigational product study within the 12 weeks preceding IMP administration. 3. History or presence of diagnosed (by an allergist/immunologist) or treated (by a physician) food or known drug allergies, or history of anaphylaxis or other severe allergic reactions. Subjects with seasonal allergies/hay fever or allergy to animals or house dust mite that are untreated and asymptomatic can be enrolled in the study based on Investigatorââ?¬•s discretion. 4. History of convulsion (including intravenous drug or vaccine-induced episodes). A medical history of a single febrile convulsion during childhood is not an exclusion criterion. 5. Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immuno-deficiencies), insulin-dependent and non-insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, porphyria, psoriasis, rheumatoid arthritis, asthma (excluding childhood asthma, or mild asthma with preventative asthma medication required less than monthly), epilepsy, or obsessive-compulsive disorder. 6. History of malignancy of any organ system treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases. 7. Subjects with history of schizophrenia, bi-polar disease, psychoses, disorders requiring lithium, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis. 8. Subjects who have received psychiatric medications within 1 year prior to enrolment, or who have been hospitalized within 5 years prior to enrolment for either a psychiatric illness or due to danger to self or others. 9. History of more than one previous episode of major depression, any previous single episode of major depression lasting for or requiring treatment for more than 6 months, or any episode of major depression during the 5 years preceding screening. 10. History of recurrent headache (e.g. tension-type, cluster or migraine) with a frequency of ââ?°Â¥2 episodes per month on average and/or severe enough to require medical therapy, during the 5 years preceding screening. 11. Presence of clinically significant infectious disease or fever (e.g. Body temperature ââ?°Â¥38Ã?°C or 100.4Ã?°F) within the 14 days prior to enrollment. 12. Evidence of acute illness within the 4 weeks prior to screening that the Investigator deems may compromise subject safety. 13. Significant inter-current disease of any type, in particular liver, renal, cardiac, pulmonary, neurologic, gastro intestinal, rheumatologic, or autoimmune disease by history, physical examination, and/or laboratory studies including urinalysis. 14. Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion (e.g. gastrectomy, diarrhoea). 15. Blood donation of any volume within 1 month before IMP administration, or participation in any research study involving blood sampling (more than 450 mL/unit of blood), or blood donation to blood bank during the 12 weeks prior to IMP administ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of ZY-19489 administered to healthy subjects.Timepoint: Baseline to End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory -To explore effect of gender on the pharmacokinetics of ZY-19489 and its metabolite ZY-20486. Timepoint: Baseline to End of study;To assess the effect of ZY-19489/ZY-20486 on the QTc interval (concentration/QTc modelling).Timepoint: Baseline to End of study;To characterize the pharmacokinetics of ZY-19489 and its metabolite ZY-20486 when administered to healthy subjectsTimepoint: Baseline to End of study;To compare Pharmacokinetics of ZY-19489 between Indian and Australian Population (Data from QP18C07 trial) (Part-1 only)Timepoint: Baseline to End of study | — |
Countries
India
Contacts
Public ContactDr Kevinkumar Kansagra
Cadila Healthcare Limited
Outcome results
None listed