A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)

NCT ID: NCT01396005

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-12-31

Brief Summary

In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will be given boceprevir. Blood samples will be taken at specified intervals to find out whether boceprevir affects the pharmacokinetics of methadone, buprenorphine, or naloxone.

Conditions

Hepatitis C Virus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methadone + boceprevir

Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg \[4 x 200 mg capsules\], orally, every 8 hours) on Days 2 through 7)

Group Type: EXPERIMENTAL

boceprevir

Intervention Type: DRUG

boceprevir 800 mg (4 x 200 mg capsules), orally, every 8 hours, Day 2 through Day 7

methadone

Intervention Type: DRUG

methadone, 20-150 mg tablets, liquid, or disket, orally, once per day, Day 1 through Day 8

Buprenorphine/naloxone + boceprevir

Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg \[4 x 200 mg capsules\], orally, every 8 hours) on Days 2 through 7

Group Type: EXPERIMENTAL

boceprevir

Intervention Type: DRUG

boceprevir 800 mg (4 x 200 mg capsules), orally, every 8 hours, Day 2 through Day 7

buprenorphine/naloxone

Intervention Type: DRUG

buprenorphine/naloxone 8/2-24/6 mg, tablets, sublingual, once per day, Day 1 through Day 8

Interventions

boceprevir

boceprevir 800 mg (4 x 200 mg capsules), orally, every 8 hours, Day 2 through Day 7

Intervention Type: DRUG

methadone

methadone, 20-150 mg tablets, liquid, or disket, orally, once per day, Day 1 through Day 8

Intervention Type: DRUG

buprenorphine/naloxone

buprenorphine/naloxone 8/2-24/6 mg, tablets, sublingual, once per day, Day 1 through Day 8

Intervention Type: DRUG

Other Intervention Names

SCH 503034, Victrelis™

Eligibility Criteria

Inclusion Criteria

• Body Mass Index (BMI) between 18 and 36, inclusive
• Reliable participation in a methadone maintenance or buprenorphine maintenance or buprenorphine/naloxone maintenance program for at least two (2) months prior to Day 1.
• Is receiving once daily oral dose of methadone therapy at a stable

individualized dose for at least 4 weeks, receiving once

daily buprenorphine dose at a stable individualized dose for at 4 weeks with, if on buprenorphine only therapy, naloxone added for at least 2 weeks prior to Day 1.

• 12-lead electrocardiogram (ECG) conduction intervals within gender-specific normal range
• Vital signs within normal range
• Clinical laboratory tests within normal range
• Women who are postmenopausal, surgically sterilized, or premenopausal and use a medically-accepted method of contraception.

Exclusion Criteria

• Pregnancy, breast feeding, or intention to become pregnant or father a child while on study or within 3 months after end of trial
• History or presence of inflammatory bowel disease, ulcers, or gastrointestinal or rectal bleeding
• History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
• History of pancreatic injury or pancreatitis
• History or presence of liver disease or liver injury
• History or presence of impaired renal function
• History of urinary obstruction or difficulty in voiding
• History of any infectious disease within 4 weeks prior to drug administration that in the opinion of the investigator, affects the subject's ability to participate in the trial
• Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
• Positive screen for drugs with a high potential for abuse such as cocaine, amphetamines, methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines, or opiates/opioids
• Excessive use of alcohol in the 2 weeks prior to Day -1, defined as greater than 3 glasses of alcoholic beverages (1 is approximately equivalent to: beer [284 mL/10 oz], wine

[125 mL/4 oz], or distilled spirits [25 mL/1 oz]) per day.

• Blood donation in the past 60 days
• Previous administration of SCH 503034 (boceprevir)
• Current participation in another clinical study or participation in a clinical study (e.g., laboratory or clinical evaluation) within 30 days of baseline
• Study staff personnel or family members of the study staff personnel
• Demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) that, in the opinion of the investigator and sponsor, interfere with their ability to participate in the trial
• History of malignancy within 5 years from Screening
• Consumption of excessive amounts (equivalent to > 6 cups of brewed coffee/day) of coffee, tea, cola or other caffeinated beverages
• Receipt of any of the following more recently than the washout period prior to Baseline: inhibitors or inducers of cytochrome (CYP) P450, CYP2B6, CYP3A4, and CYP2D6; or oral contraceptives containing drospirenone

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Hulskotte EG, Bruce RD, Feng HP, Webster LR, Xuan F, Lin WH, O'Mara E, Wagner JA, Butterton JR. Pharmacokinetic interaction between HCV protease inhibitor boceprevir and methadone or buprenorphine in subjects on stable maintenance therapy. Eur J Clin Pharmacol. 2015 Mar;71(3):303-11. doi: 10.1007/s00228-014-1789-4. Epub 2015 Feb 11.

Reference Type: RESULT

PMID: 25666027 (View on PubMed)

Other Identifiers

P08123

Identifier Type: -

Identifier Source: org_study_id