VX-950-TiDP24-C133 - A Phase I Study Investigating the Interaction Between Telaprevir and Escitalopram
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ClinicalTrials.gov Identifier: NCT00933894 |
Recruitment Status :
Completed
First Posted : July 7, 2009
Last Update Posted : December 17, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C | Drug: Telaprevir; Escitalopram | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I, Open-label, Randomized, Crossover Trial in 16 Healthy Subjects to Investigate the Potential Pharmacokinetic Interaction Between Telaprevir and Escitalopram at Steady-state |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | November 2009 |

- To investigate the effect at steady-state of TVR 750 mg q8h on the steady-state pharmacokinetics of escitalopram 10 mg q.d. in healthy participants and vica versa. [ Time Frame: pk profiles of TVR will be measured up to 8 hours after intake of the morning dose on Day 7 and 14 of Treatment B. Pharmacokinetic profiles of escitalopram will be measured up to 24 hours postdose on Day 7of Treatment A and Day 14 of Treatment B. ]
- The short-term safety and tolerability of coadministration of TVR and escitalopram in healthy participants [ Time Frame: This will be determined throughout the study; at all study visits ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933894
Study Director: | Tibotec-Virco Virology BVBA Clinical Trial | Tibotec BVBA |
Responsible Party: | Compound Development Team Leader, Tibotec Pharmaceuticals, Ireland |
ClinicalTrials.gov Identifier: | NCT00933894 |
Other Study ID Numbers: |
CR016303 |
First Posted: | July 7, 2009 Key Record Dates |
Last Update Posted: | December 17, 2010 |
Last Verified: | December 2010 |
VX-950-TiDP24-C133 VX-950-C133 VX950 |
HCV telaprevir escitalopram |
Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Citalopram Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |