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.

An Open-Label, Two-Period, Single Sequence, Cross-Over, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Dose Erythromycin on the Pharmacokinetics of GRC 17536 After a Single Dose in Healthy Male Subjects.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/01/005417

Enrollment

Registered

2015-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: GRC 17536: single oral dose on day 1 in period I and and day 7 in period II Intervention2: Erythromycin: orally three times a day in period II for 20 days Control Intervention1: Not App

Eligibility

Inclusion criteria

Inclusion criteria: 1. Normal healthy male volunteers of >=18 to 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactSivakumar Vaidyanathan

Glenmark Pharmaceuticals Ltd

monika.tandon@glenmarkpharma.com912267720000

Outcome results