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Trial record 16 of 26 for:    "Hepatitis" | "Guaifenesin"

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

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ClinicalTrials.gov Identifier: NCT01396005
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : March 11, 2013
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus
Interventions Drug: boceprevir
Drug: methadone
Drug: buprenorphine/naloxone
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Methadone + Boceprevir Buprenorphine/Naloxone + Boceprevir
Hide Arm/Group Description 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) 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
Period Title: Overall Study
Started 10 11
Completed 10 9
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             1
Non-compliance with protocol             0             1
Arm/Group Title Methadone + Boceprevir Buprenorphine/Naloxone + Boceprevir Total
Hide Arm/Group Description 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) 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 Total of all reporting groups
Overall Number of Baseline Participants 10 11 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 21 participants
34.2  (10.2) 33.2  (29.0) 33.7  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
Female
2
  20.0%
2
  18.2%
4
  19.0%
Male
8
  80.0%
9
  81.8%
17
  81.0%
1.Primary Outcome
Title Area Under the Concentration Versus Time Curve (AUC) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir
Hide Description AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.
Time Frame Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving standard methadone maintenance therapy + boceprevir
Arm/Group Title Methadone Alone Methadone + Boceprevir
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (ng.hr/mL)/mg
R-methadone
50.1
(29%)
42.4
(23%)
S-methadone
56.9
(52%)
44.6
(43%)
2.Primary Outcome
Title Maximum Concentration (Cmax) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir
Hide Description Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.
Time Frame Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving standard methadone maintenance therapy + boceprevir
Arm/Group Title Methadone Alone Methadone + Boceprevir
Hide Arm/Group Description:
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)
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)
Overall Number of Participants Analyzed 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (ng/mL)/mg
R-methadone
2.94
(22%)
2.63
(59%)
S-methadone
3.69
(39%)
3.07
(69%)
3.Primary Outcome
Title AUC of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir
Hide Description AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.
Time Frame Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants on Day 1; 2 participants were discontinued from study (Days 2-8).
Arm/Group Title Buprenorphine/Naloxone Alone Buprenorphine/Naloxone + Boceprevir
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 11 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (pg.hr/mL)/mg
3020
(55%)
4040
(43%)
4.Primary Outcome
Title Cmax of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir
Hide Description Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.
Time Frame Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants on Day 1; 1 participant discontinued from study on Day 6.
Arm/Group Title Buprenorphine/Naloxone Alone Buprenorphine/Naloxone + Boceprevir
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 11 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (pg/mL)/mg
440
(52%)
545
(45%)
5.Secondary Outcome
Title AUC of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir
Hide Description AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.
Time Frame Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants on Day 1; 2 participants were discontinued from study (Days 2-8).
Arm/Group Title Buprenorphine/Naloxone Alone Buprenorphine/Naloxone + Boceprevir
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 11 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (pg.hr/mL)/mg
157
(62%)
224
(56%)
6.Secondary Outcome
Title Cmax of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir
Hide Description Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.
Time Frame Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants on Day 1; 1 participant discontinued on Day 6.
Arm/Group Title Buprenorphine/Naloxone Alone Buprenorphine/Naloxone + Boceprevir
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 11 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (pg/mL)/mg
58.5
(87%)
65.2
(70%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methadone + Boceprevir Buprenorphine/Naloxone + Boceprevir
Hide Arm/Group Description 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) 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
All-Cause Mortality
Methadone + Boceprevir Buprenorphine/Naloxone + Boceprevir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Methadone + Boceprevir Buprenorphine/Naloxone + Boceprevir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Methadone + Boceprevir Buprenorphine/Naloxone + Boceprevir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      9/11 (81.82%)    
Gastrointestinal disorders     
Abdominal pain upper  1  1/10 (10.00%)  1 0/11 (0.00%)  0
Dry mouth  1  2/10 (20.00%)  2 1/11 (9.09%)  1
Flatulence  1  1/10 (10.00%)  1 0/11 (0.00%)  0
Nausea  1  3/10 (30.00%)  3 2/11 (18.18%)  3
Vomiting  1  2/10 (20.00%)  2 0/11 (0.00%)  0
General disorders     
Product taste abnormal  1  2/10 (20.00%)  2 1/11 (9.09%)  1
Infections and infestations     
Pharyngitis streptococcal  1  0/10 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  1/10 (10.00%)  1 0/11 (0.00%)  0
Nervous system disorders     
Dysgeusia  1  2/10 (20.00%)  2 5/11 (45.45%)  5
Headache  1  3/10 (30.00%)  4 3/11 (27.27%)  4
Somnolence  1  3/10 (30.00%)  3 0/11 (0.00%)  0
Renal and urinary disorders     
Pollakiuria  1  2/10 (20.00%)  2 2/11 (18.18%)  2
Respiratory, thoracic and mediastinal disorders     
Throat irritation  1  1/10 (10.00%)  1 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders     
Erythema  1  0/10 (0.00%)  0 1/11 (9.09%)  1
Pruritus  1  0/10 (0.00%)  0 1/11 (9.09%)  1
Pruritus generalized  1  0/10 (0.00%)  0 1/11 (9.09%)  1
Vascular disorders     
Thrombophlebitis  1  0/10 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6327
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01396005     History of Changes
Other Study ID Numbers: P08123
First Submitted: June 28, 2011
First Posted: July 18, 2011
Results First Submitted: December 6, 2012
Results First Posted: March 11, 2013
Last Update Posted: April 7, 2017