A phase I, open-label, randomized crossover trial in 24 healthy subjects to investigate the effect of steady-state esomeprazole on the pharmacokinetics of a single dose of telaprevir.

Completed

• Conditions: viral leverinflammation; 10047438; contagius jaundice

• Registration Number: NL-OMON31863
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Male or female, aged between 18-55 years of age (extremes included).
Females, postmenopausal for at least 2 years, or posthysterectomy or post-tubal ligation.
Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months before study screening.
A body mass index of 18 to 30 kg/m^2 (extremes included)

Exclusion Criteria

Clinical significant abnormalities at screening

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics<br /><br><br /><br>For more specifications see the protocol.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate the safety and tolerability.<br /><br><br /><br>For more specifications see the protocol.</p><br>