This study involves research and the objective of this study is to evaluate how much and how fast TMC278 is absorbed into the body after administration as these concept pediatric formulations compared to when administered as the 25 mg TMC278 tablet…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Compare the oral bioavailability of 3 concept pediatric formulations of TMC278
(solution, suspension, granules) to that of the adult 25 mg Phase III tablet
formulation. In addition, the absorption of TMC278 into the body will be
compared when the pediatric formulations are administered on an empty stomach
and after a breakfast.
Secondary outcome
The safety and tolerability of TMC278 different formulations during the study
period to be assessed. Finally, the palatability of each concept pediatric
formulation under fasted conditions will be evaluated.
Background summary
This new investigational drug called TMC278 is in process of development for
the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infection, an
infection that can lead to AIDS.
TMC278 is not yet approved for use by the US Food and Drug Administration and
other Regulatory Authorities in the European Union (EU). Therefore, it can only
be used in a research study.
TMC278 belongs to a class of drugs called non-nucleoside reverse transcriptase
inhibitors (NNRTIs), which help to slow or stop the progression of HIV
infection. The currently available TMC278 formulation for adults is a tablet.
Development of an appropriate formulation of TMC278 for use in children is
ongoing. A pediatric formulation must allow for flexibility in dosing depending
on age and body weight. Currently, 3 concept pediatric formulations have been
identified for further evaluation: an oral solution, an oral suspension and
granules.
Study objective
This study involves research and the objective of this study is to evaluate how
much and how fast TMC278 is absorbed into the body after administration as
these concept pediatric formulations compared to when administered as the 25 mg
TMC278 tablet for adults. In addition, the absorption of TMC278 into the body
will be compared when the pediatric formulations are administered on an empty
stomach and after a breakfast. The safety and tolerability of administration of
the different TMC278 formulations will be assessed throughout the study. This
trial will aid in the selection of a concept pediatric formulation of TMC278
for further development. Finally, the appreciation of the different flavor
formulations TMC278 will be examined.
Study design
Open label, randomised, cross-over study.
Intervention
Dosing with 25 mg TMC278 per treatment.
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, venapunctions and
the introduction of the cannula. All volunteers are closely monitored and
supervised by experienced doctors and studystaff for possible side effects.
The following tests will be performed during this trial: physical examination,
measuring bloodpressure and hart rate, blood- and urine tests, pregnancy test
(women only), drugscreen, alcohol tests, taste questionnaires, restrictions in
living habits, standardized meals during admission.
Al volunteers will be closely monitored by experienced physicians and staff.
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland
Dr. Paul Janssenweg 150
5026 RH Tilburg
Nederland
Listed location countries
Age
Inclusion criteria
1) Age between 18 and 55 years
2) Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes a day for at least 3 months prior to selection.
3) BMI 18.0-30.0.
4) Signed ICF
5) Able to comply with protocol requirements
6) Healthy based on the basis of a medical evaluation.
Exclusion criteria
1) Positive HIV and Hepatitis testresults.
2) Female except if they are of non-childbearing potential.
3) History or evidence of alcohol and or drug abuse.
4) Hepatitis A, B en C
5) Positive urine drug test
6) Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease.
7) Currently significant diarrhea, gastric stasis or constipation that in the investigator's opinion could influence drug absorption or bioavailability.
8) Any history of significant skin disease such as but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis or urticaria.
9) Previously demonstrated clinically significant allergy or hypersensitivity to and/or any of the excipients of the investigational medication administered on this trial.
10) Use of concomitant medication, including over-the-counter products and dietary supplements. Systemic over-the-counter medication must have been discontinued at least 7 days prior to the first dose of study medication; prescribed medications must have been discontinued at least 14 days before the first dose of study medication, except for paracetamol and ibuprofen.
11) Participation in an investigational drug trial within 60 days prior to the first intake of trial medication.
12) Donation of blood plasma within the 60 days preceding the first intake of trial medication.
13) Lab abnormalities
14) Having participated in more than 1 trial (single or multiple dose) with TMC125 (etravine), TMC120 (dapirivine) and/or TMC278 (rilpivirine, formerly known as R278474) or having developed rash, erythema or urticaria while participating in a trial with the aforementioned compounds.
15) Significant heart rhythm disturbances.
16) Subjects with ageusia, hypogeusia or dysgeusia
17) Renal impairment: calculated creatinine clearance (CLCr) < 80 mL/min;
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 | EUCTR2008-007101-36-NL |
| CCMO | NL25895.040.08 |