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Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01532973
First received: February 10, 2012
Last updated: October 3, 2016
Last verified: October 2016
Results First Received: October 3, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hepatitis, Viral, Human
Interventions: Drug: Elbasvir
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 Panels (Panel D in Part 1 and Panel H in Part 2) were planned but not performed. No participants were enrolled in either of these panels.

Reporting Groups
  Description
GT1 HCV 10-mg Elbasvir (Panel A) Participants with genotype (GT) 1 hepatitis C virus (HCV) receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
GT1 HCV 50-g Elbasvir (Panel B) Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
GT1 HCV 5-mg Elbasvir (Panel C) Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
GT1 HCV 200-mg Elbasvir (Panel D) Participants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
GT3 HCV 10-mg Elbasvir (Panel E) Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
GT3 HCV 50-mg Elbasvir (Panel F) Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
GT3 HCV 100-mg Elbasvir (Panel G) Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
GT3 HCV 200-mg Elbasvir (Panel H) Participants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
GT1a HCV 10-mg Elbasvir (Panel I) Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
GT1a HCV 50-mg Elbasvir (Panel J) Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.

Participant Flow for 3 periods

Period 1:   Part 1
    GT1 HCV 10-mg Elbasvir (Panel A)   GT1 HCV 50-g Elbasvir (Panel B)   GT1 HCV 5-mg Elbasvir (Panel C)   GT1 HCV 200-mg Elbasvir (Panel D)   GT3 HCV 10-mg Elbasvir (Panel E)   GT3 HCV 50-mg Elbasvir (Panel F)   GT3 HCV 100-mg Elbasvir (Panel G)   GT3 HCV 200-mg Elbasvir (Panel H)   GT1a HCV 10-mg Elbasvir (Panel I)   GT1a HCV 50-mg Elbasvir (Panel J)
STARTED   6   6   6   0 [1]   0   0   0   0   0   0 
COMPLETED   6   6   6   0   0   0   0   0   0   0 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0 
[1] Planned panel not performed. No participants were enrolled.

Period 2:   Part 2
    GT1 HCV 10-mg Elbasvir (Panel A)   GT1 HCV 50-g Elbasvir (Panel B)   GT1 HCV 5-mg Elbasvir (Panel C)   GT1 HCV 200-mg Elbasvir (Panel D)   GT3 HCV 10-mg Elbasvir (Panel E)   GT3 HCV 50-mg Elbasvir (Panel F)   GT3 HCV 100-mg Elbasvir (Panel G)   GT3 HCV 200-mg Elbasvir (Panel H)   GT1a HCV 10-mg Elbasvir (Panel I)   GT1a HCV 50-mg Elbasvir (Panel J)
STARTED   0   0   0   0   6   6   6   0 [1]   0   0 
COMPLETED   0   0   0   0   6   6   6   0   0   0 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0 
[1] Planned panel not performed. No participants were enrolled.

Period 3:   Part 3
    GT1 HCV 10-mg Elbasvir (Panel A)   GT1 HCV 50-g Elbasvir (Panel B)   GT1 HCV 5-mg Elbasvir (Panel C)   GT1 HCV 200-mg Elbasvir (Panel D)   GT3 HCV 10-mg Elbasvir (Panel E)   GT3 HCV 50-mg Elbasvir (Panel F)   GT3 HCV 100-mg Elbasvir (Panel G)   GT3 HCV 200-mg Elbasvir (Panel H)   GT1a HCV 10-mg Elbasvir (Panel I)   GT1a HCV 50-mg Elbasvir (Panel J)
STARTED   0   0   0   0   0   0   0   0   6   6 
COMPLETED   0   0   0   0   0   0   0   0   6   6 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants who received at least one dose of study drug. Participants who received placebo in Part 1, 2, or 3 are grouped together regardless of HCV GT or randomly assigned panel. 2 Panels (Panel D in Part 1 and Panel H in Part 2) were planned but not performed. No participants were enrolled in either of these panels.

Reporting Groups
  Description
GT1 HCV 10-mg Elbasvir (Panel A) Participants with GT1 Hepatitis who received 10 -mg elbasvir for 5 consecutive days during Part I of the study.
GT1 HCV 50-g Elbasvir (Panel B) Participants with GT1 HCV receive 50-mg elbasvir for 5 consecutive days during Part I of the study.
GT1 HCV 5-mg Elbasvir (Panel C) Participants with GT1 HCV receive 5-mg elbasvir for 5 consecutive days during Part I of the study.
GT3 HCV 10-mg Elbasvir (Panel E) Participants with GT3 HCV receive 10-mg elbasvir for 5 consecutive days during Part II of the study.
GT3 HCV 50-mg Elbasvir (Panel F) Participants with GT3 HCV receive 50-mg elbasvir for 5 consecutive days during Part II of the study.
GT3 HCV 100-mg Elbasvir (Panel G) Participants with GT3 HCV receive 100-mg elbasvir for 5 consecutive days during Part II of the study.
GT1a HCV 10-mg Elbasvir (Panel I) Participants with GT1a only HCV receive 10-mg elbasvir for 5 consecutive days during Part III of the study.
GT1a HCV 50-mg Elbasvir (Panel J) Participants with GT1a only HCV receive 50-mg elbasvir for 5 consecutive days during Part III of the study.
Placebo Participants with GT1, GT3 or GT1a HCV who received placebo in Parts I, II, or II of the study.
Total Total of all reporting groups

Baseline Measures
   GT1 HCV 10-mg Elbasvir (Panel A)   GT1 HCV 50-g Elbasvir (Panel B)   GT1 HCV 5-mg Elbasvir (Panel C)   GT3 HCV 10-mg Elbasvir (Panel E)   GT3 HCV 50-mg Elbasvir (Panel F)   GT3 HCV 100-mg Elbasvir (Panel G)   GT1a HCV 10-mg Elbasvir (Panel I)   GT1a HCV 50-mg Elbasvir (Panel J)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   5   5   5   5   5   5   8   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.8  (10.8)   36.8  (6.9)   51.6  (8.8)   34.8  (6.4)   35.8  (8.9)   34.6  (6.8)   51.0  (5.0)   53.2  (11.6)   47.8  (10.8)   43.0  (11.0) 
Gender 
[Units: Participants]
                   
Female   0   0   0   0   0   0   0   0   0   0 
Male   5   5   5   5   5   5   5   5   8   48 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1   [ Time Frame: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5 ]

2.  Primary:   Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3   [ Time Frame: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5 ]

3.  Primary:   Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a   [ Time Frame: Baseline (Predose on Day 1) and 24-hour post-dose on Day 5 ]

4.  Primary:   Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1   [ Time Frame: Up to 5 days ]

5.  Primary:   Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3   [ Time Frame: Up to 5 days ]

6.  Primary:   Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a   [ Time Frame: Up to 5 days ]

7.  Primary:   Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5   [ Time Frame: Up to 5 days ]

8.  Primary:   Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event   [ Time Frame: Up to 5 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck, Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01532973     History of Changes
Other Study ID Numbers: 8742-002
2011-005190-23 ( EudraCT Number )
Study First Received: February 10, 2012
Results First Received: October 3, 2016
Last Updated: October 3, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices