A study to evaluate the safety, tolerability, and pharmacokinetics of a single dose of the drug F-652 in healthy male volunteers.

Phase 1

• Conditions: Alcoholic Hepatitis; Inflammatory and Immune System - Other inflammatory or immune system disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612000713897
• Lead Sponsor: Generon Corporation Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

1.No clinically signifcant findings in medical history and physical examination, especially normal hepatic and renal function.

2. BMI >19 and < 30mg/m2

3. No clinically significant laboratory values and urinalysis

4. Normal Quantiferon test, ECG, blood pressure and heart rate

5. Aged between 18 and 45 years

Exclusion Criteria

1. Family history of premature Coronary Heart Disease (CHD)

2. Any condition requiring regular use of medication

3. Exposure to prescription medication or to drugs known to interfere with metabolism of drugs within 14 days prior to screening.

4. Current or history of malignancy disease

5. Haemorrhoids or anal disease with regular or recent presence of blood in faeces.

6. Presence or sequelae of hepatics and renal disease, or other medical conditions known to intefere with the absorption, distribution, metabolism and excretion of drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events post investigational drug administration. Adverse events are defined as any changes observed relative to baseline observation (screening) and include but not limited to the following:<br>1. Changes in physical appearance e.g. bruising, bloodshot eyes, etc.<br>2. Significant changes blood parameters<br>3. Changes in general well being e.g. headache, fatigue, etc[From enrolment into the study (Screening) until the end of the study on Day 22 post drug administration.]

Secondary Outcome Measures

Name	Time	Method
evels of F-652 (Investigational Drug) in serum samples[Pharmacokinetics samples will be taken at Pre-dose, 1, 2, 4 8, 16, 24, 36 hours and 3, 4, 5, 6, 8, 11, 15, 22 days after investigational drug administration]