A Phase I, open-label, randomized, 2-way crossover trial in 40 healthy subjects to investigate the potential pharmacokinetic interactions between telaprevir and darunavir/ritonavir and between telaprevir and fosamprenavir/ritonavir at steady-state

• Conditions: hepatitis C / liver disease; 10047438

• Registration Number: NL-OMON32330
• Lead Sponsor: TIBOTEC PHARMACEUTICALS In Nederland vertegenwoordigd door Janssen-Cilag B.V. afdeling GCO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

-male or female aged between 18-55 year
-females should be amenorrheal for at least 3 years, or post-hystorectomy or post-tubal ligation
-nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day
-normal weight at screening (BMI 18-30 kg/m2)
-healthy based on the assessments performed at screening

Exclusion Criteria

-subjects with a history of any illness that, in the opinion of the investigator or the subject*s general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
-current use of prescription medication
-Regular treatment with over-the-counter medications. Subjects 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
-consumption of herbal medication or dietary supplements and grapefruit and grapfruit juice, apple juice, orange juice within 14 days before first administration of studymedication
-consumption of more than 2 units alcoholic beverages per dag er 14 per week
-consumption of more an avarage of more than 5 servings of coffee or other caffeinated beverages per day
-a history of drug or alcohol abuse or addiction, or who test positive for alcohol or drugs such as cannabis, cocaine, amphetamines, benzodiazepines, or opiates during the screening period
-participation in a clinical study involving administration of an investigational drug within 3 months
-donation of any blood or having had a significant loss of blood within 3 months
-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 subjects with female partners that are pregnant, or planning to become pregnant during the study or within 90 days of the last dose of study medication
-having participated previously in a trial with telaprevir (VX-950)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to determine the effect of co-administration of<br /><br>telepravir, given as 2 tablets of 375 mg every 8 hours and DRV/rtv or fAPV/rtv<br /><br>on the amount of telaprevir and DRV/rtv or fAPV/rtv in the body. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective is to determine the effect of telaprevir and DRV/rtv or<br /><br>fAPV/rtv on the amount of telaprevir and DRV/rtv and fAPV/rtv in the body when<br /><br>telaprevir is taken as two tablets of 375 mg every 12 hours instead of the<br /><br>regimen of two tablets every 8 hours. Additionally, the study wants to<br /><br>investigate the short term safety and tolerability of the concomitant use of<br /><br>telaprevir and DRV/rtv, as well as telaprevir and fAPV/rtv in healthy subjects.</p><br>