Status:
COMPLETED
VX-950-TiDP24-C133 - A Phase I Study Investigating the Interaction Between Telaprevir and Escitalopram
Lead Sponsor:
Tibotec BVBA
Conditions:
Hepatitis C
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the effect of steady-state telaprevir (TVR) 750 mg q8h (3 times a day, every 8 hours) on the steady-state pharmacokinetics of escitalopram 10 mg q.d. (once ...
Detailed Description
Telaprevir is being investigated for treatment of chronic HCV infection, in combination with Peg-IFN (pegylated interferon) and RBV (ribavirin). Peg-IFN plus RBV are currently an accepted methode for ...
Eligibility Criteria
Inclusion
- Females should be post-menopausal for at least 2 years (amenorrheal for at least 3 years), or have undergone tubal ligation (or other permanent birth control methods), or hysterectomy (total), or oophorectomy (bilateral), and should not be breastfeeding
- Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months before study screening
- Body mass index (BMI, weight in kg divided by the square of height in meters) of 18 to 30 kg/m2, extremes included, at study screening
- normal 12-lead ECG at screening
- Healthy on the basis of a physical examination, medical history, vital signs, and the results of blood chemistry, hematological and coagulation tests and urinalysis carried out at screening
Exclusion
- Participants should stop any short-duration courses of prescription medication at least 14 days before first intake of study medication, potential participants should not stop any chronic, prescribed medication being taken at the direction of a physician, without obtaining agreement from that physician
- Participants should stop over-the-counter medications on the date of the screening visit but no less than 7 days prior to the first administration of study medication, potential participants should not stop any chronic, over-the-counter medication being taken at the direction of a physician, without obtaining agreement from that physician
- Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 glass \[285 mL\] of beer, 1 glass \[125 mL\] of wine, 25 mL shot of 40% spirit) from 14 days before the first intake of study medication until completion of the pharmacokinetic sampling in the last treatment session
- Participants may not consume any alcohol 72 hours before or after study drug administration
- Positive test for any of the following infectious disease tests: hepatitis A infection (confirmed by hepatitis A antibody IgM), hepatitis B antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus 1 antibody (HIV1Ab), or human immunodeficiency virus 2 antibody (HIV2Ab)
- Male participants with female partners that are planning to become pregnant during the study or within 90 days of the last dose of study medication
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00933894
Start Date
September 1 2009
End Date
November 1 2009
Last Update
December 17 2010
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