Status:
COMPLETED
TMC278-TiDP6-C154: Evaluation of the Possible Influence of Omeprazole Intake - and the pH Increase in the Stomach Triggered by Omeprazole Intake - on the Blood Levels of TMC278 in Healthy Volunteers
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the extent by which intake of 20 mg once daily (q.d.) omeprazole influences the levels of TMC278 in the blood after intake of 25 mg q.d.. This study also in...
Detailed Description
This is an open label study, which means that all parties including the study doctor, the healthy volunteer and the sponsor plus his designees will know at all times which treatment the volunteer is i...
Eligibility Criteria
Inclusion
- Smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day (or non-smoking) for at least 3 months prior to selection
- Weight as defined by a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
- Informed Consent Form (ICF) signed voluntarily
- Able to comply with protocol requirements
- Healthy on the basis of a pretrial physical examination, medical history, the results of blood biochemistry and hematology tests, a urinalysis, vital signs, and a 12-lead electrocardiogram (ECG)
Exclusion
- No positive testing for HIV-1 or -2
- females, except if menopausal for at least 2 years, or with total hysterectomy or bilateral tubal ligation (without repair surgery)
- No infection of Hepatitis A, B or C
- No currently active gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease
- No history of clinically relevant heart rhythm disturbances
- No positive urine drug testing
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01001247
Start Date
January 1 2010
End Date
April 1 2010
Last Update
July 9 2010
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