None listed
Conditions
Interventions
Intervention1: MKP 10241 Suspension: MKP 10241 Suspension of Mankind
Pharma Limited
Control Intervention1: Placebo: Placebo product of Mankind
Pharma Limited
Sponsors
Mankind Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 18 and 55 years (both inclusive). 2. Subjects weight within normal range according to normal values for Body Mass Index (18.5 to 30.0 kg/m2 (both inclusive)) with minimum of 50 kg weight. 3. Subjects with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable reference range. 4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG). 5. Subjects having clinically acceptable chest X-Ray (PA view), if taken. 6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine). 7. Subjects having negative alcohol breath test or urine alcohol test. 8. Subjects should be non-smokers and non-alcoholic 9. Subjects willing to adhere to the protocol requirements and to provide written informed consent. 10. For male subjects: Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) Condom with spermicide, Condom with diaphragm, or abstinence or subjects should also not donate sperm during this time.
Exclusion criteria
Exclusion criteria: 1. History or presence of significant cardiovascular (e.g. tachyarrhythmia or ischemic heart disease or congestive heart failure), pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 2. Use of any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission of period 01. 3. Presence of significant alcoholism or drug abuse. 4. History or presence of asthma, urticaria or other significant allergic reactions. 5. History or presence of significant gastric and/or duodenal ulceration. 6. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor. 7. History or presence of cancer or basal or squamous cell carcinoma. 8. History or presence of narrow angle glaucoma. 9. Difficulty with donating blood. 10. Use of any prescribed medication during the last one month or OTC medication (including vitamins and herbal remedies) during last 30 days prior to dosing in period 01. 11. Major illness within past 3 months. 12. Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug. 13. Consumption of xanthine-containing products, tobaccocontaining products or alcohol within the 48 hours prior to admission in period 01. 14. Consumption of grapefruit or grapefruit juice within the 72 hours prior to admission in period 01. 15. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C. 16. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study. 17. History or presence of significant easy bruising or bleeding. 18. History or presence of significant recent trauma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of the Different dose levels of MKP 10241 after single-dose administration and after multiple-dose administrationTimepoint: After completion of each cohort (for each dose level), DSMB (Data Safety Monitoring Board) will discuss the safety and tolerability of the subjects. Decision on selection of doses and further way forward will be based on DSMB committee discretion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Multiple Ascending Dose (MAD) To characterize the multiple-dose pharmacokinetic profiles of MKP 10241 in human subjectsTimepoint: For MAD A total of 23 blood samples will be collected for pharmacokinetic evaluation in each dose level of the study. Pre-dose blood sample of 5.0 mL will be collected at 0.00 (5 min prior to the dosing) hr on day 01, day 05, day 06 and day 07 prior to the dosing. The post-dose blood samples of 5.0 mL each will be drawn at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours after dosing of Day 07.;Multiple Ascending Dose (MAD) To evaluate the change in thymus toxicity marker Human CCL17 (TARC) after multiple-dose administration of MKP 10241 in human subjectsTimepoint: A total 2 samples of 3.0 ml each for Human CCL17 (TARC) will be collected at 0.00hr (pre dose of day 01) and at day 10 (i.e 72.00 hr post last dose). Note: Based on DSMB review, ethic committee and regulatory suggestion extra sample for Human CCL17 (TARC) will be collected.;Multiple Ascending Dose (MAD) To evaluate the Dose proportionality after multiple dose.Timepoint: NA;Multiple Ascending Dose (MAD) To evaluate the lowering of blood glucose, Insulin, glucogon, GLP-1 (total and active)after multiple-dose administration of MKP 10241 in human subjects.Timepoint: A total of 17 blood samples will be collected in each dose level of the study. Sample of 5.0 mL for Insulin and Glucagon measurement will be collected at 0.00 hr. (pre-dose) of day 01 to day 7 and at 0.50, 1.00, 2.00, 3.00 , 4.00 and 24.00 hr. post dose of day 07. Sample for GLP-1 (total and active) will be collected on 0.00 hr. (pre-dose) of day 01 to day 7 at 0.00 hr. (pre dose) and 03.00, 04.00, 06.00, 08.00, 12.00, 24.00 and 48.00 hr. post dose.;Single Ascending Dose (SAD) To characterize the single-dose pharmacokinetic profiles of MKP 10241 in humansubjectsTimepoint: For SAD A total of 20 blood samples wil | — |
Countries
India
Contacts
Public ContactDr. Darshan kumar Kharadi
Veeda Clinical Research Ltd.
Outcome results
None listed