A pharmacokinetic study of novel formulations of ISC 17536 in healthy male adults
- Registration Number
- CTRI/2020/09/028094
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 108
1. Normal healthy male of 18 to 45 years of age (both inclusive) at the time of initial written informed consent.
2. Body mass index (BMI) >= 18.5 kg/m2 and <= 24.9 kg/m2 (both inclusive), and weight >=50 kg at screening.
3. Provide written informed consent prior to any protocol-related procedures, including screening evaluations. Subject must be able to understand the consent form and instructions and to provide consent directly; no guardian or caregiver may provide consent for the subject.
4. Negative for drugs of abuse at check-in.
5. Negative for alcohol consumption at check-in.
6. Able and willing to abstain from methylxanthine-containing beverages or food (coffee, tea, chocolate, caffeinated sodas, cola or â??power drinksâ??) from 48h prior to admission on D-1 and throughout the study through the final end-of-study visit (on D25).
7. Able and willing to abstain from grapefruit juice from 7 days prior to admission on D-1 and throughout the study duration, through D25.
8. Non-smokers and those who have not consumed tobacco or tobacco products at least for last 12 months and willing to abstain from smoking and the use of other tobacco-containing or nicotine-containing products (including but not limited to cigarettes, hookah, vaping, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) or use of any electronic cigarette for vaping (including with non-nicotine containing chemicals) throughout the study until D25.
9. Negative urine cotinine test at screening and at admission to CRU.
10. Men of child bearing potential must agree to protocol-specified contraception requirements.
1. Has clinically significant results on physical examination, medical history, 12-lead ECG, chest X-ray, or lab investigations that would increase risk to the subject by participating in the study, as determined by the Investigator.
2. History of relevant drug allergies, food allergies or known allergy to ISC 17536 or its excipients, as determined by the Investigator.
3. History of clinically significant (as determined by the Investigator) hematologic, renal, endocrine, pulmonary, GI (presence of active peptic ulcer disease, GI bleeding, chronic gastritis, gastric bypass surgery, inflammatory bowel disease or chronic diarrhea), cardiovascular, hepatic, psychiatric, neurologic (including any active seizure disorder requiring therapy with antiepileptic drugs, head injury or untreated convulsion), or allergic disease (including drug allergies, but excluding untreated, mild seasonal allergies).
4. Clinically significant alcohol or drug abuse/addiction as determined by the Investigator.
5. Positive Hepatitis B Virus Surface Antigen (HBsAg) or Hepatitis B antibody to core protein, Hepatitis C Virus Antibody (HCV Ab) or antibodies to the human immunodeficiency virus (HIV-1/2 Antibody [HIV-1/2 Ab]).
6. History of liver disease or any abnormal liver function tests at screening [Alanine Aminotransferase (ALT)/ Aspartate Aminotransferase (AST)/Alkaline Phosphatase (ALP)/Bilirubin (BILI)) >1.5x upper limit of normal (ULN)].
7. Clinically significant ECG abnormalities at screening including:
- An abnormal PR interval considered by the investigator as clinically significant (>= 220 msec or <= 100 msec), OR
- QTc prolongation (QTcF >= 450 msec), OR
- Sinus bradycardia ( <40 beats per minute [bpm]), sick sinus syndrome, second- or third-degree atrioventricular block, any type of tachycardia, left bundle-branch block, asymptomatic unifocal atrialrhythm), OR
- Any history of myocardial ischemia/infarction (either changes suggesting acute ischemia/infarction or changes from previous tracings compatible with the infarction), OR
- Heart rate <40 bpm or >100 bpm that is considered clinically significant by the investigator.
8. Supine systolic blood pressure (SYSBP) >=140 mm Hg or <=90 mm Hg or a supine diastolic BP (DIABP) >=90 mm Hg or <=50 mm Hg.
9. Has acute GI symptoms at the time of screening or at admission to CRU (eg. nausea, vomiting, diarrhea, heartburn).
10. Received any investigational drug in any clinical study within 3 months or less than 5 half-lives prior to screening, or are on extended follow-up from such a clinical study.
11. Previous randomization in any ISC 17536 study.
12. Received moderate or strong inhibitors or inducers of CYP3A4 enzymes during the 30 days or 5 half-lives prior to screening, whichever is longer (including but not limited to the drugs listed in excluded medication).
13. Received herbal/Ayurveda medication/supplements, St Johnâ??s wort, or any food or drink containing grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (eg, cauliflower, cabbage and cruciferous vegetables; kale, broccoli, watercress, collard greens, kohlrabi, brussel sprouts, mustard) or charbroiled meat within 24 hours prior to admission (Day -1).
14. Has taken any medications, including over-the-counter (OTC) medications, within 14 days before study drug adm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method