To Evaluate the Effect of Multiple Dose Erythromycin on the Pharmacokinetics (action of drug in the body) of GRC 17536 After a Single Dose in Healthy Male Subjects.
- Registration Number
- CTRI/2015/01/005417
- Lead Sponsor
- Glenmark Pharmaceuticals SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Normal healthy male volunteers of >=18 to <= 45 years of age.
2. Healthy as determined by medical history, physical examination, chest X-ray, 12-lead ECG and laboratory investigations.
3. Able and willing to abstain from methylxanthine-containing beverages or food.
4. Non-smokers or ex-smokers for at least 12 months with history of less than a 10-pack per year.
1. Have abnormal and clinically significant results on the physical examination, medical history, chest X-ray, 12-lead ECG and lab investigations.
2. Volunteers with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
3. History of alcohol abuse or drug addiction as seen on positive screen on drugs of abuse or positive alcohol breath test.
4. Positive screen on hepatitis-B surface antigen (HBsAg), antibodies to the Hepatitis C virus (anti-HCV) or antibodies to the human immunodeficiency virus (HIV) 1/2; or rapid plasma reagin or VDRL.
5. Subjects with known history of liver disease or any abnormal liver function tests at screening.
6. Current diagnosis of active epilepsy or any active seizure disorder requiring therapy with antiepileptic drug(s.
7. History of hypersensitivity to erythromycin or other macrolide compound; or past history of hepatic impairment, hepatitis or cholestatic hepatitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Systemic exposure of GRC 17536 alone and in combination with erythromycin; characterized by maximum plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC0-tlast and AUC0-â??).Timepoint: 20 days
- Secondary Outcome Measures
Name Time Method Adverse event (AE) recording, clinical laboratory measures, vital sign parameters, electrocardiograms (ECGs), and physical examinations with GRC 17536 alone and in combination with erythromycin.Timepoint: 38 days