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

NCT00933283 | Completed Phase 1

• 2 other identifiers: CR015931VX-950-TiDP24-C135
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Participants

Keywords

Healthy participants; Pharmacokinetics; Pharmacodynamic; Potential interaction; VX-950-TiDP24-C135; VX-950; Methadone; Telaprevir; Steady-state

Outcome Measures

Primary Outcomes (9)

• Maximum plasma concentration (Cmax) of telaprevir

  Pharmacokinetic parameter Cmax of telaprevir is measured when telaprevir will be administered at 750 mg every 8 hours for 7 days added to stable methadone maintenance therapy.

  On Day 7

• Minimum plasma concentration (Cmin) of telaprevir

  Pharmacokinetic parameter Cmin of telaprevir is measured when telaprevir will be administered every 8 hours for 7 days added to stable methadone maintenance therapy.

  On Day 7

• Area under the plasma concentration-time curve (AUC) of telaprevir

  Pharmacokinetic parameter AUC of telaprevir is measured when telaprevir will be administered every 8 hours for 7 days added to stable methadone maintenance therapy.

  On Day 7

• Cmax of R-methadone

  Pharmacokinetic parameter Cmax of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir at 750 mg every 8 hours.

  Day -1 and Day 7

• Cmin of R-methadone

  Pharmacokinetic parameter Cmin of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.

  Day -1 and Day 7

• AUC of R-methadone

  Pharmacokinetic parameter AUC of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.

  Day -1 and Day 7

• Cmax of S-methadone

  Pharmacokinetic parameter Cmax of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir at 750 mg every 8 hours.

  Day -1 and Day 7

• Cmin of S-methadone

  Pharmacokinetic parameter Cmin of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.

  Day -1 and Day 7

• AUC of S-methadone

  Pharmacokinetic parameter AUC of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours.

  Day -1 and Day 7

Secondary Outcomes (4)

• Short Opiate Withdrawal Scale [SOWS]

  Day -7, and Day -2 to Day 7

• Desires for Drugs Questionnaire [DDQ]

  Day -7, and Day -2 to Day 7

• Pupillometry

  Day -1, Day 2, Day 4, and Day 7

• Number of participants with adverse events

  Up to 60 days

Study Arms (1)

Telaprevir + Methadone

EXPERIMENTAL

Patients will receive telaprevir 750 mg orally, every 8 hours from Day 1 to Day 7, along with methadone 30 to 130 mg, once daily.

Drug: Telaprevir; Drug: Methadone

Interventions

Telaprevir DRUG

Telaprevir 750 mg will be administered orally, every 8 hours from Day 1 to Day 7, along with methadone, once daily.

Telaprevir + Methadone

Methadone DRUG

Methadone 30 to 130 mg will be administered as a stable oral therapy from Day -14 to Day -1, in combination with telaprevir from Day 1 to Day 7, and then alone as a continued intake dose for an additional 30 to 32 days.

Telaprevir + Methadone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tibotec BVBA: lead
• Vertex Pharmaceuticals Incorporated: collaborator

Related Publications (1)

• van Heeswijk R, Verboven P, Vandevoorde A, Vinck P, Snoeys J, Boogaerts G, De Paepe E, Van Solingen-Ristea R, Witek J, Garg V. Pharmacokinetic interaction between telaprevir and methadone. Antimicrob Agents Chemother. 2013 May;57(5):2304-9. doi: 10.1128/AAC.02262-12. Epub 2013 Mar 11.

  PMID: 23478952 DERIVED

Related Links

• A Phase I, open-label, single-sequence drug-drug interaction trial in subjects on stable methadone maintenance therapy, to investigate the potential interaction between telaprevir 750 mg q8h and methadone, at steady-state.

MeSH Terms

Interventions

telaprevir; Methadone

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Tibotec-Virco Virology BVBA Clinical Trial

  Tibotec BVBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 7, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 3, 2012

Record last verified: 2012-11