A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)
Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00998985
Collaborator
(none)
91
14
32.5
Study Details
Study Description
Brief Summary
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
91 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Grazoprevir (MK-5172) in Hepatitis C Infected Male Patients
Actual Study Start Date
:
Feb 23, 2010
Actual Primary Completion Date
:
Nov 8, 2012
Actual Study Completion Date
:
Nov 8, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 400 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 600 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 800 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 400 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 600 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 800 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 200 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 100 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 50 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 200 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 100 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 50 mg Grazoprevir - GT3 GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 30 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
| Experimental: 10 mg Grazoprevir - GT1 GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo |
Drug: Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Drug: Placebo
Placebo tablet, orally, once a day for 7 days
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Clinical and Laboratory Adverse Events (AEs) [All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)]
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Secondary Outcome Measures
- Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7 [Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose]
Blood samples were collected on Day 7 at pre-dose up to 24 hours post-dose in order to determine the AUC 0-24hrs of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir AUC0-24hr. exceeds 3.2 uM.hr.
- 24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7 [Day 7 at 24 hours post-dose]
Blood samples were collected on Day 7 at 24 hours post-dose in order to determine the C24hr of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir C24hr exceeds 28 nM.
- Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo [Baseline and up to approximately 2 months]
Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA, expressed in international units (IU)/mL.
- Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo [Baseline and up to approximately 2 months]
Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Baseline health is stable.
-
Has a clinical diagnosis of chronic HCV infection.
Exclusion Criteria:
-
Has a history of stroke or chronic seizures.
-
Has a history of cancer.
-
Has a history of human immunodeficiency virus (HIV) infection.
-
Has had major surgery, donated blood or participated in another investigational study within the past 3 months.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT00998985
Other Study ID Numbers:
- 5172-004
- 2009_678
- 2009-015563-13
First Posted:
Oct 21, 2009
Last Update Posted:
Jul 17, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | One of the originally planned treatment groups (50 mg Grazoprevir - GT3) was not conducted because other results indicated that further evaluation of 50 mg Grazoprevir in GT3 participants was not necessary. It is therefore not included in the Participant Flow. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 400 mg Grazoprevir - GT1 | 600 mg Grazoprevir - GT1 | 800 mg Grazoprevir - GT1 | 400 mg Grazoprevir - GT3 | 600 mg Grazoprevir - GT3 | 800 mg Grazoprevir - GT3 | 200 mg Grazoprevir - GT1 | 100 mg Grazoprevir - GT1 | 50 mg Grazoprevir - GT1 | 200 mg Grazoprevir - GT3 | 100 mg Grazoprevir - GT3 | 30 mg Grazoprevir - GT1 | 10 mg Grazoprevir - GT1 | Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days |
| Period Title: Overall Study | ||||||||||||||
| STARTED | 5 | 5 | 15 | 5 | 5 | 5 | 5 | 5 | 6 | 5 | 5 | 5 | 5 | 15 |
| COMPLETED | 5 | 5 | 15 | 5 | 5 | 4 | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 15 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 400 mg Grazoprevir - GT1 | 600 mg Grazoprevir - GT1 | 800 mg Grazoprevir - GT1 | 400 mg Grazoprevir - GT3 | 600 mg Grazoprevir - GT3 | 800 mg Grazoprevir - GT3 | 200 mg Grazoprevir - GT1 | 100 mg Grazoprevir - GT1 | 50 mg Grazoprevir - GT1 | 200 mg Grazoprevir - GT3 | 100 mg Grazoprevir - GT3 | 30 mg Grazoprevir - GT1 | 10 mg Grazoprevir - GT1 | Placebo for Grazoprevir - GT1 and GT3 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days | Total of all reporting groups |
| Overall Participants | 5 | 5 | 15 | 5 | 5 | 5 | 5 | 5 | 6 | 5 | 5 | 5 | 5 | 15 | 91 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||||||||||
| Mean (Standard Deviation) [Years] |
42.4
(12.8)
|
47.2
(12.2)
|
46.7
(9.7)
|
42.8
(14.4)
|
38.0
(13.1)
|
46.2
(10.8)
|
51.0
(16.2)
|
48.4
(5.9)
|
36.8
(6.0)
|
40.0
(10.2)
|
31.4
(6.3)
|
55.8
(5.4)
|
48.4
(13.1)
|
45.6
(11.5)
|
44.7
(11.5)
|
| Sex: Female, Male (Count of Participants) | |||||||||||||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
5
100%
|
5
100%
|
15
100%
|
5
100%
|
5
100%
|
5
100%
|
5
100%
|
5
100%
|
6
100%
|
5
100%
|
5
100%
|
5
100%
|
5
100%
|
15
100%
|
91
100%
|
Outcome Measures
| Title | Number of Participants With Clinical and Laboratory Adverse Events (AEs) |
|---|---|
| Description | An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE. |
| Time Frame | All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of the investigational drug according to the treatment(s) they actually received. Participants with either GT1 or GT3 who received the same treatment were combined for the summary into a single GT1 and GT3 arm. |
| Arm/Group Title | 400 mg Grazoprevir - GT1 and GT3 | 600 mg Grazoprevir - GT1 and GT3 | 800 mg Grazoprevir - GT1 and GT3 | 200 mg Grazoprevir - GT1 and GT3 | 100 mg Grazoprevir - GT1 and GT3 | 50 mg Grazoprevir - GT1 | 30 mg Grazoprevir - GT1 | 10 mg Grazoprevir - GT1 | Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days |
| Measure Participants | 10 | 10 | 20 | 10 | 10 | 6 | 5 | 5 | 15 |
| Number [Participants] |
6
120%
|
3
60%
|
13
86.7%
|
4
80%
|
1
20%
|
0
0%
|
3
60%
|
4
80%
|
2
33.3%
|
| Title | Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7 |
|---|---|
| Description | Blood samples were collected on Day 7 at pre-dose up to 24 hours post-dose in order to determine the AUC 0-24hrs of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir AUC0-24hr. exceeds 3.2 uM.hr. |
| Time Frame | Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir. |
| Arm/Group Title | 400 mg Grazoprevir - GT1 and GT3 | 600 mg Grazoprevir - GT1 and GT3 | 800 mg Grazoprevir - GT1 and GT3 | 200 mg Grazoprevir - GT1 and GT3 | 100 mg Grazoprevir - GT1 and GT3 | 50 mg Grazoprevir - GT1 | 30 mg Grazoprevir - GT1 | 10 mg Grazoprevir - GT1 | Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days |
| Measure Participants | 10 | 10 | 18 | 10 | 10 | 5 | 5 | 5 | 0 |
| Geometric Mean (90% Confidence Interval) [uM.hr] |
18.2
|
41.9
|
72.5
|
3.21
|
1.16
|
0.419
|
0.260
|
0.0628
|
| Title | 24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7 |
|---|---|
| Description | Blood samples were collected on Day 7 at 24 hours post-dose in order to determine the C24hr of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir C24hr exceeds 28 nM. |
| Time Frame | Day 7 at 24 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir. |
| Arm/Group Title | 400 mg Grazoprevir - GT1 and GT3 | 600 mg Grazoprevir - GT1 and GT3 | 800 mg Grazoprevir - GT1 and GT3 | 200 mg Grazoprevir - GT1 and GT3 | 100 mg Grazoprevir - GT1 and GT3 | 50 mg Grazoprevir - GT1 | 30 mg Grazoprevir - GT1 | 10 mg Grazoprevir - GT1 | Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days |
| Measure Participants | 10 | 10 | 18 | 10 | 10 | 5 | 5 | 5 | 0 |
| Geometric Mean (90% Confidence Interval) [nM] |
70.2
|
93.2
|
174
|
22.2
|
20.1
|
12.7
|
7.20
|
2.41
|
| Title | Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo |
|---|---|
| Description | Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA, expressed in international units (IU)/mL. |
| Time Frame | Baseline and up to approximately 2 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT1 participant treated with 50 mg grazoprevir, who discontinued, and all GT3 participants treated with grazoprevir were excluded from analysis. |
| Arm/Group Title | 400 mg Grazoprevir - GT1 | 600 mg Grazoprevir - GT1 | 800 mg Grazoprevir - GT1 | 200 mg Grazoprevir - GT1 | 100 mg Grazoprevir - GT1 | 50 mg Grazoprevir - GT1 | 30 mg Grazoprevir - GT1 | 10 mg Grazoprevir - GT1 | Placebo for Grazoprevir - GT1 and GT3 | 400 mg Grazoprevir - GT3 | 600 mg Grazoprevir - GT3 | 800 mg Grazoprevir - GT3 | 200 mg Grazoprevir - GT3 | 100 mg Grazoprevir - GT3 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days | Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days |
| Measure Participants | 5 | 5 | 15 | 5 | 5 | 5 | 5 | 5 | 15 | 0 | 0 | 0 | 0 | 0 |
| Least Squares Mean (95% Confidence Interval) [log10 IU/mL] |
5.14
|
5.32
|
5.72
|
5.53
|
4.74
|
5.26
|
5.06
|
3.84
|
0.39
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 10 mg Grazoprevir - GT1, Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean (LSM) Difference |
| Estimated Value | 3.46 | |
| Confidence Interval |
(2-Sided) 90% 2.89 to 4.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 30 mg Grazoprevir - GT1, Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM Difference |
| Estimated Value | 4.68 | |
| Confidence Interval |
(2-Sided) 90% 4.11 to 5.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 50 mg Grazoprevir - GT1, Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM Difference |
| Estimated Value | 4.87 | |
| Confidence Interval |
(2-Sided) 90% 4.30 to 5.44 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 100 mg Grazoprevir - GT1 and GT3, Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM Difference |
| Estimated Value | 4.35 | |
| Confidence Interval |
(2-Sided) 90% 3.78 to 4.92 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 200 mg Grazoprevir - GT1 and GT3, Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM Difference |
| Estimated Value | 5.15 | |
| Confidence Interval |
(2-Sided) 90% 4.58 to 5.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 400 mg Grazoprevir - GT1 and GT3, Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM Difference |
| Estimated Value | 4.76 | |
| Confidence Interval |
(2-Sided) 90% 4.19 to 5.33 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | 600 mg Grazoprevir - GT1 and GT3, Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM Difference |
| Estimated Value | 4.93 | |
| Confidence Interval |
(2-Sided) 90% 4.36 to 5.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | 800 mg Grazoprevir - GT1 and GT3, Placebo for Grazoprevir - GT1 and GT3 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM Difference |
| Estimated Value | 5.34 | |
| Confidence Interval |
(2-Sided) 90% 4.93 to 5.74 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
| Title | Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo |
|---|---|
| Description | Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA. |
| Time Frame | Baseline and up to approximately 2 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT3 participant treated with 800 mg grazoprevir, who discontinued, and all GT1 participants were excluded from analysis. |
| Arm/Group Title | 400 mg Grazoprevir - GT3 | 600 mg Grazoprevir - GT3 | 800 mg Grazoprevir - GT3 | 200 mg Grazoprevir - GT3 | 100 mg Grazoprevir - GT3 | Placebo for Grazoprevir - GT1 and GT3 | 800 mg Grazoprevir - GT1 | 600 mg Grazoprevir - GT1 | 400 mg Grazoprevir - GT1 | 200 mg Grazoprevir - GT1 | 100 mg Grazoprevir - GT1 | 50 mg Grazoprevir - GT1 | 30 mg Grazoprevir - GT1 | 10 mg Grazoprevir - GT1 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days |
| Measure Participants | 5 | 5 | 4 | 5 | 5 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Least Squares Mean (95% Confidence Interval) [log10 IU/mL] |
4.23
|
5.36
|
4.60
|
3.32
|
2.64
|
0.39
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 100 mg Grazoprevir - GT1 and GT3, 50 mg Grazoprevir - GT1 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM Difference |
| Estimated Value | 2.25 | |
| Confidence Interval |
(2-Sided) 90% 1.70 to 2.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 200 mg Grazoprevir - GT1 and GT3, 50 mg Grazoprevir - GT1 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM Difference |
| Estimated Value | 2.94 | |
| Confidence Interval |
(2-Sided) 90% 2.38 to 3.49 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 400 mg Grazoprevir - GT1 and GT3, 50 mg Grazoprevir - GT1 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM Difference |
| Estimated Value | 3.84 | |
| Confidence Interval |
(2-Sided) 90% 3.29 to 4.40 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 600 mg Grazoprevir - GT1 and GT3, 50 mg Grazoprevir - GT1 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM difference |
| Estimated Value | 4.98 | |
| Confidence Interval |
(2-Sided) 90% 4.42 to 5.53 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 800 mg Grazoprevir - GT1 and GT3, 50 mg Grazoprevir - GT1 |
|---|---|---|
| Comments | It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | LSM difference |
| Estimated Value | 4.21 | |
| Confidence Interval |
(2-Sided) 90% 3.60 to 4.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment. | |
Adverse Events
| Time Frame | All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All participants who received at least one dose of drug according to the treatment(s) they actually received. Participants with either GT1 or GT3 who received the same treatment are combined into a single GT1 and GT3 arm. | |||||||||||||||||
| Arm/Group Title | 400 mg Grazoprevir - GT1 and GT3 | 600 mg Grazoprevir - GT1 and GT3 | 800 mg Grazoprevir - GT1 and GT3 | 200 mg Grazoprevir - GT1 and GT3 | 100 mg Grazoprevir - GT1 and GT3 | 50 mg Grazoprevir - GT1 | 30 mg Grazoprevir - GT1 | 10 mg Grazoprevir - GT1 | Placebo for Grazoprevir - GT1 and GT3 | |||||||||
| Arm/Group Description | GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days | GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days | |||||||||
All Cause Mortality |
||||||||||||||||||
| 400 mg Grazoprevir - GT1 and GT3 | 600 mg Grazoprevir - GT1 and GT3 | 800 mg Grazoprevir - GT1 and GT3 | 200 mg Grazoprevir - GT1 and GT3 | 100 mg Grazoprevir - GT1 and GT3 | 50 mg Grazoprevir - GT1 | 30 mg Grazoprevir - GT1 | 10 mg Grazoprevir - GT1 | Placebo for Grazoprevir - GT1 and GT3 | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| 400 mg Grazoprevir - GT1 and GT3 | 600 mg Grazoprevir - GT1 and GT3 | 800 mg Grazoprevir - GT1 and GT3 | 200 mg Grazoprevir - GT1 and GT3 | 100 mg Grazoprevir - GT1 and GT3 | 50 mg Grazoprevir - GT1 | 30 mg Grazoprevir - GT1 | 10 mg Grazoprevir - GT1 | Placebo for Grazoprevir - GT1 and GT3 | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/10 (0%) | 0/20 (0%) | 0/10 (0%) | 0/10 (0%) | 0/6 (0%) | 0/5 (0%) | 0/5 (0%) | 0/15 (0%) | |||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| 400 mg Grazoprevir - GT1 and GT3 | 600 mg Grazoprevir - GT1 and GT3 | 800 mg Grazoprevir - GT1 and GT3 | 200 mg Grazoprevir - GT1 and GT3 | 100 mg Grazoprevir - GT1 and GT3 | 50 mg Grazoprevir - GT1 | 30 mg Grazoprevir - GT1 | 10 mg Grazoprevir - GT1 | Placebo for Grazoprevir - GT1 and GT3 | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/10 (60%) | 3/10 (30%) | 13/20 (65%) | 4/10 (40%) | 1/10 (10%) | 0/6 (0%) | 3/5 (60%) | 4/5 (80%) | 2/15 (13.3%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| Abdominal pain | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Abdominal pain upper | 1/10 (10%) | 1 | 1/10 (10%) | 2 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Aphthous stomatitis | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 1/10 (10%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Diarrhoea | 1/10 (10%) | 1 | 1/10 (10%) | 1 | 6/20 (30%) | 10 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Flatulence | 1/10 (10%) | 1 | 0/10 (0%) | 0 | 1/20 (5%) | 1 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 2/5 (40%) | 2 | 1/5 (20%) | 1 | 1/15 (6.7%) | 1 |
| Nausea | 1/10 (10%) | 1 | 0/10 (0%) | 0 | 1/20 (5%) | 1 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Toothache | 1/10 (10%) | 3 | 0/10 (0%) | 0 | 1/20 (5%) | 1 | 1/10 (10%) | 1 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/15 (0%) | 0 |
| Vomiting | 1/10 (10%) | 1 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| General disorders | ||||||||||||||||||
| Fatigue | 3/10 (30%) | 3 | 0/10 (0%) | 0 | 4/20 (20%) | 5 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Vessel puncture site haematoma | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 1/10 (10%) | 1 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Infections and infestations | ||||||||||||||||||
| Nasopharyngitis | 1/10 (10%) | 1 | 1/10 (10%) | 1 | 3/20 (15%) | 3 | 0/10 (0%) | 0 | 1/10 (10%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 2 | 0/15 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||||
| Contusion | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/15 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Back pain | 1/10 (10%) | 1 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Pain in extremity | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 1/5 (20%) | 1 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||||
| Dysgeusia | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 1/5 (20%) | 1 | 0/15 (0%) | 0 |
| Headache | 3/10 (30%) | 5 | 0/10 (0%) | 0 | 8/20 (40%) | 11 | 3/10 (30%) | 3 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 2/5 (40%) | 3 | 1/15 (6.7%) | 2 |
| Migraine | 1/10 (10%) | 2 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||||||
| Insomnia | 1/10 (10%) | 1 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||||
| Erectile dysfunction | 1/10 (10%) | 1 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Oropharyngeal pain | 1/10 (10%) | 1 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||||
| Macule | 1/10 (10%) | 1 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Night sweats | 1/10 (10%) | 1 | 0/10 (0%) | 0 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
| Pruritus | 1/10 (10%) | 1 | 1/10 (10%) | 1 | 0/20 (0%) | 0 | 0/10 (0%) | 0 | 0/10 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 | 0/5 (0%) | 0 | 0/15 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
Results Point of Contact
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp. |
| Phone | 1-800-672-6372 |
| ClinicalTrialsDisclosure@merck.com |
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT00998985
Other Study ID Numbers:
- 5172-004
- 2009_678
- 2009-015563-13
First Posted:
Oct 21, 2009
Last Update Posted:
Jul 17, 2018
Last Verified:
Jun 1, 2018