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

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 - VX-950HPC1002

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37071

Enrollment

Registered

2012-05-01

Start date

2012-05-15

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy Hepatitis C

Interventions

See section E4.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	—

Secondary

Measure	Time frame
Pharmacokinetics	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)