To estimate the bioavailability (amount of drug which reaches the blood) of GRC 17536 following oral administration in normal healthy male adults.

Phase 1

Completed

• Registration Number: CTRI/2014/12/005320
• Lead Sponsor: Glenmark Pharmaceuticals SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

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 alcohol and methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, power drinks)

4. Able and willing to abstain from smoking and the use of other tobacco products

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. Subjects who have received any investigational drug in any clinical trial within last 3 months, or who are on extended follow-up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systemic exposure of GRC 17536 - Cmax, AUC <br/ ><br>Timepoint: 22 days

Secondary Outcome Measures

Name	Time	Method
Adverse EventsTimepoint: 22 days;Clinical Parameters (Vitals, Physical Examination)Timepoint: 22 days;Laboratory ParametersTimepoint: 22 days;T1/2Timepoint: 22 days;TmaxTimepoint: 22 days