Overview

A Study to Investigate the Potential Interaction Between Telaprevir and Methadone, at Steady-State

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effect of steady-state (constant concentration of medication in the blood) telaprevir 750 mg every 8 hours on the steady-state pharmacokinetics (how the drug concentrations change over time) of R- and S-methadone.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Tibotec BVBA
Collaborator:
Vertex Pharmaceuticals Incorporated
Treatments:
Methadone
Criteria
Inclusion Criteria:

- Must receive once daily oral methadone maintenance therapy at a stable individualized
dose of 30 to 130 mg for at least 2 weeks prior to screening, formulated as
commercially available tablets or solution

- Must agree not to change the current methadone dose from screening until Day 7
included to have a daily observed and documented methadone intake from Day -14 until
Day 8 and a daily observed and documented telaprevir intake from Day 1 until Day 7

- Participants have to obtain approval for participation from his/her addiction
physician, and the addiction physician has to agree to provide medical care for the
participant after discharge from study center

- General medical condition must not interfere with the assessments and the completion
of the study

- Health assessments will be done on the basis of physical examination, medical history,
electrocardiogram, vital signs and the results of blood biochemistry, blood
coagulation and hematology tests and a urinalysis carried out at screening

Exclusion Criteria:

- History of any illness that could confound the results of the study or pose an
additional risk in administering study medication to the participant, for eg, history
of relevant medication or food allergies, history of cardiovascular or central nervous
system disease, history or presence of clinically significant pathology or history of
mental disease

- Consumption of herbal medications or dietary supplements, vitamins, and grapefruit or
grapefruit juice, apple juice or orange juice within 14 days before Day -1

- Current alcohol use, which, in the assessment of the investigator, could compromise
participant's safety or compliance with the study protocol procedures

- Test positive for drugs of abuse such as cocaine, amphetamines, barbiturates,
benzodiazepines, or opiates on Day -2 unless explained by allowed concomitant
medications

- Participation in a clinical study involving administration of an investigational
medication within 60 days or 5 half-lives (whichever was longer) prior to the
screening visit