A Phase I, open-label, randomized, 2-panel, sequential treatment study in healthy subjects to investigate the potential pharmacokinetic interactions between multiple doses of phenytoin or carbamazepine and telaprevir at steady-state

Completed

• Conditions: Epilepsy; Hepatitis C; 10047438; 10039911

• Registration Number: NL-OMON37071
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

Each potential subject must satisfy all of the following criteria to be enrolled in the study.;- Be a man or woman 18 to 55 years of age, inclusive.;- If a woman, before entry she must be:;• postmenopausal for at least 2 years (amenorrheal for at least 3 years), OR;• surgically sterile (have had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of becoming pregnant).;- Non-smoking for at least 3 months prior to selection, to be confirmed by a nicotine screening test according to the local standard of care.

Exclusion Criteria

- Subjects of Asian ancestry, or previous identification as a positive carrier of the human leukocyte antigen (HLA) -B*1502.;- Hepatitis A, B or C or human immunodeficiency virus-type 1 or 2 (HIV-1 or HIV-2) infection at screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and tolerability</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics</p><br>