A Study to Investigate the Potential Pharmacokinetic Interactions Between Phenytoin or Carbamazepine and Telaprevir
Information source: Janssen Infectious Diseases BVBA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Participants
Intervention: Telaprevir (Drug); Phenytoin (Drug); Carbamazepine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Janssen Infectious Diseases BVBA Official(s) and/or principal investigator(s): Janssen Infectious Diseases BVBA Clinical Trial, Study Director, Affiliation: Janssen Infectious Diseases BVBA
Summary
The purpose of this study is to investigate the potential pharmacokinetic (what the body
does to the drug) interactions between multiple doses of phenytoin 200 mg every 12 hours or
carbamazepine 200 mg every 12 hours and telaprevir 750 mg every 8 hours at steady-state
(constant concentration of medication in the blood) in healthy participants.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Observed maximum plasma concentration (Cmax) of telaprevir.Area under the plasma concentration time curve from time of administration up to 8 hours post dose (AUC8h) of telaprevir. Observed minimum plasma concentration (Cmin) of telaprevir. Observed maximum plasma concentration (Cmax) of carbamazepine. Area under the plasma concentration time curve from time of administration up to 12 hours post dose (AUC12) of carbamazepine. Observed minimum plasma concentration (Cmin) of carbamazepine. Observed maximum plasma concentration (Cmax) of phenytoin. Area under the plasma concentration time curve from time of administration up to 12 hours post dose (AUC12) of phenytoin. Observed minimum plasma concentration (Cmin) of phenytoin.
Secondary outcome: Number of participants with adverse eventsNumber of participants with abnormal values of laboratory results Number of participants with abnormal electrocardiogram values Number of participants with abnormal pulse and blood pressure values Number of patients with abnormal physical examination findings
Detailed description:
This is a Phase I, open-label (all people know the identity of the intervention), randomized
(the study medication is assigned by chance), 2-panel, sequential treatment study. In this
study 24 healthy participants will be randomly assigned equally to 2 panels. In Panel 1 the
participants will receive telaprevir in Part 1 (telaprevir 750 mg every 8 hours from Day 1
to Day 9 followed by a single 750 mg dose in the morning on Day 10) and phenytoin/telaprevir
in Part 2 (phenytoin 200 mg every 12 hours from Day 1 to Day 16 followed by a single 200-mg
dose in the morning on Day 17; and telaprevir 750 mg every 8 hours from Day 8 to Day 16
followed by a single 750 mg dose in the morning on Day 17). In Panel 2 the participants will
receive telaprevir (telaprevir 750 mg every 8 hours from Day 1 to Day 9 followed by a single
750 mg dose in the morning on Day 10) and carbamazepine/ telaprevir (carbamazepine 200 mg
every 12 hours from Day 1 to Day 16 followed by a single 200-mg dose in the morning on Day
17; and telaprevir 750 mg every 8 hours from Day 8 to Day 16 followed by a single 200-mg
dose in the morning on Day 17). In both panels, Part 1 and Part 2 are separated by a washout
period of at least 2 weeks and maximum 4 weeks. Safety and tolerability will be assessed by
evaluating adverse events, electrocardiogram, clinical laboratory examinations, vital signs
and physical examination throughout the study period.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Must be healthy on the basis of physical examination, medical history, vital signs,
clinical laboratory tests, and electrocardiogram performed at screening
- 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)
- Men must agree to use a highly effective method of birth control (ie, male condom
with either female intrauterine device [IUD], diaphragm, cervical cap or hormone
based contraceptives by their female partner) and to not donate sperm during the
study and for 3 months after receiving the last dose of study drug
- A 12-lead electrocardiogram consistent with normal cardiac conduction and function
Exclusion Criteria:
- Participants with a history of any illness that, in the opinion of the Investigator
or the participant's general practitioner, might confound the results of the study or
pose an additional risk in administering study drug(s) to the participant
- Participants of Asian ancestry (given association of phenytoin / carbamazepine and
severe rash with HLA-B 1502 in this population)
- Current use of prescription medication, and regular use or routine use of concomitant
medication(s), including over-the-counter (OTC) products
- Consumption of herbal medications or dietary supplements (eg, St. John's Wort, Ginkgo
biloba, garlic supplements), vitamins, and grapefruit or grapefruit juice, apple
juice, or orange juice within 14 days before the first administration of study drug
- Consumption of an average of more than five 240-mL servings of coffee or other
caffeinated beverage per day
Locations and Contacts
Groningen, Netherlands
Additional Information
Starting date: May 2012
Last updated: October 23, 2013
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