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

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 - Study protocol DRL-17822/CD/001

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33454

Enrollment

Registered

2009-03-20

Start date

2009-04-20

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Atherosclerosis coronary heart disease

Interventions

The volunteers will participate in two sessions. In the one session, the investigational drug will be administered in a fasted state, in the other session the investigational drug will be administer

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 = 18.0 and

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Part I (single ascending dose): To evaluate the safety and tolerability of ascending single doses of DRL-17822 in healthy male subjects. Part II (food effect evaluation): To evaluate the effect of food on the pharmacokinetics of a single dose of DRL-17822 in healthy male subjects. Part III (multiple ascending dose): To evaluate the safety and tolerability of ascending multiple doses of DRL-17822 in healthy male subjects.	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Part I (single ascending dose): To evaluate the pharmacokinetics of ascending single doses of DRL-17822 in healthy male subjects; To determine CETP activity in the plasma of healthy male subjects following ascending single doses of DRL-17822. 2Part II (food effect evaluation): To evaluate the safety of a single dose of DRL-17822 in healthy male subjects; To determine CETP activity in the plasma of healthy male subjects following a single dose of DRL-17822. Part III (multiple ascending dose): To evaluate the pharmacokinetics of ascending multiple doses of DRL-17822 in healthy male subjects with HDL-C levels	—

Measure

Time frame

Part I (single ascending dose): To evaluate the pharmacokinetics of ascending single doses of DRL-17822 in healthy male subjects; To determine CETP activity in the plasma of healthy male subjects following ascending single doses of DRL-17822. 2Part II (food effect evaluation): To evaluate the safety of a single dose of DRL-17822 in healthy male subjects; To determine CETP activity in the plasma of healthy male subjects following a single dose of DRL-17822. Part III (multiple ascending dose): To evaluate the pharmacokinetics of ascending multiple doses of DRL-17822 in healthy male subjects with HDL-C levels

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)