To evaluate the safety, tolerability and pharmacokinetics of single-dose and multiple-dose administration of MKP 10241
- Registration Number
- CTRI/2021/09/036637
- Lead Sponsor
- Mankind Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method