A Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food on the Pharmacokinetics of DRL-17822 in Healthy Adult Male Volunteers

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 72

Inclusion Criteria

1.Male subjects, 18-45 years of age, inclusive (Parts I and II), 18-55 years of age, inclusive (Part III);
2.Body mass index (BMI) >= 18.0 and <= 28.0 kg/m2 (Parts I and II), >= 18.0 and <= 30.0 kg/m2 (Part III);
3. HDL-C levels <= 1.3 mmol/L at Screening (Part III only);
4. Informed consent;
5. Good health, based upon the results of the screening;
6.Venous access sufficient to allow blood sampling as per protocol;

Exclusion Criteria

1. Positive for hepatitis B, C or HIV;
2. Positive drug screen result at Screening or on Day -1;
3. Positive alcohol breath test result at Screening or during admission;
4. Use of prescription medication within 2 weeks prior to Day 1;
5. Use of over-the-counter medication (including homeopathic medicines) within 4 days prior to Day 1, excluding routine vitamins and incidental use of paracetamol;
6. History of clinically significant haematologic, renal, hepatic, cardiovascular, neurologic, endocrinal, oncologic, pulmonary, immunologic, or psychiatric disorders;
7. History of clinically significant allergies;
8. Unwilling to comply with contraceptive measures up to 90 days after last dosing;
9. Presence or history of alcoholism or drug abuse;
10. Use of more than 21 units of alcohol per week;
11. Smoking ;
12. Participation in an investigational drug study within 90 days prior to Day 1;
13. Loss or donation of >350 mL of blood within 90 days prior to Day 1;
14. Unsuitable to participate in the study for any reason in the opinion of the PI.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part I (single ascending dose):<br /><br>To evaluate the safety and tolerability of ascending single doses of DRL-17822<br /><br>in healthy male subjects.<br /><br><br /><br>Part II (food effect evaluation):<br /><br>To evaluate the effect of food on the pharmacokinetics of a single dose of<br /><br>DRL-17822 in healthy male subjects.<br /><br><br /><br>Part III (multiple ascending dose):<br /><br>To evaluate the safety and tolerability of ascending multiple doses of<br /><br>DRL-17822 in healthy male subjects. </p><br>

Secondary Outcome Measures