Part I (single ascending dose):To evaluate the safety and tolerability of ascending single doses of DRL-17822 in healthy male subjects;To evaluate the pharmacokinetics of ascending single doses of DRL-17822 in healthy male subjects;To determine CETP…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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 <= 1.3 mmol/L;
To determine the steady state levels of ascending multiple doses of DRL-17822
in healthy male subjects with HDL-C levels <= 1.3 mmol/L;
To evaluate the pharmacodynamic effect(s) of ascending multiple doses of
DRL-17822 in healthy male subjects with HDL-C levels <= 1.3 mmol/L.
Background summary
DRL-17822 is a new investigational drug developed to inhibit the enzyme CETP
(cholesterol ester transfer protein). CETP plays an important role with the
metabolism of HDL cholesterol (good cholesterol) to LDL cholesterol (bad
cholesterol). Studies showed that a high HDL cholesterol level and low level
LDL cholesterol gives less riscs on cardiovascular disorders. By inhibiting
CETP, the amount of HDL cholesterol will rise compared to LDL cholesterol. This
could protect against cardiovascular disorders.
Study objective
Part I (single ascending dose):
To evaluate the safety and tolerability of ascending single doses of DRL-17822
in healthy male subjects;
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 effect of food on the pharmacokinetics of a single dose of
DRL-17822 in healthy male subjects;
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 safety and tolerability of ascending multiple doses of
DRL-17822 in healthy male subjects with HDL-C levels <= 1.3 mmol/L;
To evaluate the pharmacokinetics of ascending multiple doses of DRL-17822 in
healthy male subjects with HDL-C levels <= 1.3 mmol/L;
To determine the steady state levels of ascending multiple doses of DRL-17822
in healthy male subjects with HDL-C levels <= 1.3 mmol/L;
To evaluate the pharmacodynamic effect(s) of ascending multiple doses of
DRL-17822 in healthy male subjects with HDL-C levels <= 1.3 mmol/L.
Study design
Randomised, double-blind, placebo-controlled study.
Intervention
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 administered after a breakfast.
Study burden and risks
The risks associated with this investigation are linked together with the
possible side effects of the investigational product. The burden on the
volunteer will continue to work with the recording periods, assessments
performed during the trial, venapunctions and the introduction of the cannula.
All volunteers are closely monitored and supervised by experienced doctors and
studystaff for possible side effects.
Discovery Research, Bollaram Road,
Miyapur, Hyderabad-500 049
India
Discovery Research, Bollaram Road,
Miyapur, Hyderabad-500 049
India
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-010835-41-NL |
| CCMO | NL27152.040.09 |