The objectives are:1. Compare how the body processes single and multiple doses of tapentadol for a certain period after taking the tablets. This way absorption, excretion and distribution of the drug in the body is assessed.2. Findings of the safety…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
acute en chronische pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Compare how the body processes single and multiple doses of tapentadol for a
certain period after taking the tablets. This way absorption, excretion and
distribution of the drug in the body is assessed.
Secondary outcome
Findings of the safety and tolerability.
Background summary
This study, R331333/PAI1036, tests a 250 mg tablet of tapentadol ( also known
as CG5503 base) Tamper Resistant Prolonged-release Formulation (called TRF) as
well as a single dose and a as a multiple dose in the same study. The purpose
of this study is to compare how the body handles the medicine over a period of
time (called Pharmacokinetics or PK) after the intake of the tablets between a
single dose and multiple doses of TRF and includes how the body absorbs,
distributes and eliminates medication. In addition safety and tolerability will
be assessed. Tapentadol belongs to the narcotic drugs. Tapentadol, is an
experimental drug that is being developed as an painkiller (= analgesic) for
the use in acute pain (such as postoperative pain) and in chronic pain (such as
low back pain and arthritis (joint pain).
Study objective
The objectives are:
1. Compare how the body processes single and multiple doses of tapentadol for a
certain period after taking the tablets. This way absorption, excretion and
distribution of the drug in the body is assessed.
2. Findings of the safety and tolerability.
Study design
While staying in the clinical research unit for 9 days, the study will consist
of 2 parts.
In the 1st part of the study, the subjects will receive one tablet (CG5503
base) of 250 mg TRF once.
In the 2nd part of the study, the subjects will receive a multiple dose (5
doses in total, every 12 hours) of tapentadol (CG5503 base) TRF of 250 mg.
The subjects will be in the study for approximately 4 weeks, including
screening period.
During the study, the subjects are admitted at the clinical research unit in
the evening, at least 10 hours prior to drug administration, this is on Day -1.
The subjects will stay at the clinical research unit Day 8 and may leave the
unit after collection of the last PK collection on Day 8.
Study burden and risks
The risks associated with this investigation are linked together with the
possible side effects of tapentadol. The burden on the volunteer will continue
to work with the recording periods, venapunctions and the introduction of the
cannula. All volunteers are closely monitored and supervised by experienced
doctors and studystaff for possible side effects.
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland
Listed location countries
Age
Inclusion criteria
1. Man or woman, 18 to 55 years of age, inclusive.
2. Signed informed consent.
3. Healthy on the basis of prestudy physical examination, medical history, 12-lead ECG, vital signs, and clinical laboratory parameters.
4. Received a thorough explanation of the optional pharmacogenomic research component of the study and was offered the opportunity to participate by signing the separate pharmacogenomic informed consent document.
5. Women must be postmenopausal, surgically sterile or be practicing an effective method of birth control.
6. Women must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening.
7. Body mass index between 20 and 28 kg/m2 inclusive and body weight nog less than 50kg.
8. Blood pressure between 100 and 140 mmHg systolic, inclusive, and between 50 and 90 mmHg diastolic, inclusive.
9. Habitually smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration.
Exclusion criteria
1. History of seizure disorder or epilepsy or traumatic brain injury.
2. History of gastrointestinal disease affecting absorption, gastric surgery or
history of or current significant medical illness including (but not limited
to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders (including any abnormal bleeding or blood
dyscrasias), lipid abnormalities, significant pulmonary disease (including
bronchospastic respiratory disease), diabetes mellitus, renal or hepatic
insufficiency, thyroid disease, neurologic or psychiatric disease,
infection, or any other illness that the investigator considers should
exclude the subject.
3. History of allergies.
4. History of drug or alcohol abuse.
5. Positive test for drug or alcohol abuse.
6. Donated blood, blood products or loss of blood (> 500 mL) within 2 months before the first administration of study drug.
7. Received an experimental drug or used an experimental medical device within 30 days or within a period less than 10 times the drug's half life before the first dose of the study drug is scheduled.
8. Women who plan to become pregnant during the study, or who are breast-feeding.
9. Men and women with abnormal hemoglobin concentrations.
10. Subjects who have used prescription medications and/or over-the-counter medication (incl. ibuprofen or herbal medication) within 14 days before first study drug administration, MAOI's and SNRIs within 21 days before first study drug administration, alcohol/grapefruit juice/quinine-containing drinks/seville orange products whithin 24 hours before first study drug administration, methylxanthine-containing products within 48 hours before first study drug administration.
11. Unable to swallow solid, oral dosage forms whole with the aid of water(participants may not chew, divide, dissolve, or crush the study drug).
12. Positive test for HIV and Hepatitis.
13. Preplanned surgery or procedures that would interfere with the conduct of the study.
14. Known or suspected inability to comply with the study protocol.
15. Inability to communicate meaningfully with investigator and staff.
16. Employee of the investigator or study center, as well as family member of the employees or investigator.
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 | EUCTR2008-004700-31-NL |
| CCMO | NL24498.040.08 |