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This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria of the Child-Pugh's scale) with the PK of grazoprevir when administered to healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1-Mild Hepatic Impairment (HI) | Experimental | Participants with mild hepatic impairment will receive 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study. |
|
| Part 1-Healthy Matched to Mild HI | Experimental | Healthy participants will receive 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study. |
|
| Part 2-Moderate HI | Experimental | Participants with moderate hepatic impairment will receive 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. |
|
| Part 2-Healthy Matched to Moderate HI | Experimental | Healthy participants will receive 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. |
|
| Part 3-Severe HI | Experimental | Participants with severe hepatic impairment will receive 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grazoprevir | Drug | Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24) of Grazoprevir | Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma AUC0-24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose |
| Maximum Concentration (Cmax) of Grazoprevir | Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Cmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose |
| Time to Peak Concentration (Tmax) of Grazoprevir | Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Tmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose |
| Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Mild HI and Moderate HI and Healthy Matched to Mild HI and Moderate HI | Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Day 1 at 24 hours postdose |
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Inclusion Criteria:
Hepatic Insufficiency Participants Only:
Matched Healthy Participants Only:
- In good health based on medical history, physical examination, vital signs, and laboratory safety tests
Exclusion Criteria:
Hepatic Insufficiency Participants Only:
- Has a history of hepatitis C infection by serology, regardless of most recent viral load status.
Matched Healthy Participants Only:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28947470 | Result | Caro L, Wenning L, Guo Z, Fraser IP, Fandozzi C, Talaty J, Panebianco D, Ho M, Uemura N, Reitmann C, Angus P, Gane E, Marbury T, Smith WB, Iwamoto M, Butterton JR, Yeh WW. Effect of Hepatic Impairment on the Pharmacokinetics of Grazoprevir, a Hepatitis C Virus Protease Inhibitor. Antimicrob Agents Chemother. 2017 Nov 22;61(12):e00813-17. doi: 10.1128/AAC.00813-17. Print 2017 Dec. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1-Mild Hepatic Impairment (HI) | Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study. |
| FG001 | Part 1-Healthy Matched to Mild HI | Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study. |
| FG002 | Part 2-Moderate HI | Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. |
| FG003 | Part 2-Healthy Matched to Moderate HI | Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. |
| FG004 | Part 3-Severe HI | Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study. |
| FG005 | Part 3-Healthy Matched to Severe HI | Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1-Mild HI | Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study. |
| BG001 | Part 1-Healthy Matched to Mild HI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24) of Grazoprevir | Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma AUC0-24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | uM*hr | Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose |
|
14 days after last dose (up to Day 24)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1-Mild HI | Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C578009 | grazoprevir |
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| Part 3-Healthy Matched to Severe HI | Experimental | Healthy participants will receive 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study. |
|
| Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Severe HI and Healthy Matched to Severe HI |
Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. |
| Day 1 at 24 hours postdose |
| Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 10 | Blood samples were collected at 24 hours post-dose on Day 10 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Days 10 at 24 hours postdose |
| Apparent Terminal Half-life (t1/2) of Grazoprevir | Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Day 10 in order to determine the plasma t1/2 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Day 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose |
| Withdrawal by Subject |
|
Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
| BG002 | Part 2-Moderate HI | Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. |
| BG003 | Part 2-Healthy Matched to Moderate HI | Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. |
| BG004 | Part 3-Severe HI | Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study. |
| BG005 | Part 3-Healthy Matched to Severe HI | Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study. |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Part 1-Healthy Matched to Mild HI | Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study. |
| OG002 | Part 2-Moderate HI | Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. |
| OG003 | Part 2-Healthy Matched to Moderate HI | Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. |
| OG004 | Part 3-Severe HI | Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study. |
| OG005 | Part 3-Healthy Matched to Severe HI | Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study. |
|
|
|
| Primary | Maximum Concentration (Cmax) of Grazoprevir | Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Cmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | uM | Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose |
|
|
|
|
| Primary | Time to Peak Concentration (Tmax) of Grazoprevir | Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Tmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Median | Full Range | hr. | Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose |
|
|
|
| Primary | Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Mild HI and Moderate HI and Healthy Matched to Mild HI and Moderate HI | Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Severe HI and Matched Healthy to Severe HI are absent because they had a different Measure Type and Method of Dispersion | Posted | Geometric Mean | 95% Confidence Interval | nM | Day 1 at 24 hours postdose |
|
|
|
|
| Primary | Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Severe HI and Healthy Matched to Severe HI | Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Mild HI, Moderate HI and Healthy Matched to Mild HI or Moderate HI are absent because they had a different Measure Type and Method of Dispersion | Posted | Median | Full Range | nM | Day 1 at 24 hours postdose |
|
|
|
| Primary | Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 10 | Blood samples were collected at 24 hours post-dose on Day 10 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | nM | Days 10 at 24 hours postdose |
|
|
|
|
| Primary | Apparent Terminal Half-life (t1/2) of Grazoprevir | Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Day 10 in order to determine the plasma t1/2 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI. | Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr. | Day 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose |
|
|
|
| 0 |
| 8 |
| 8 |
| 8 |
| EG001 | Part 1-Healthy Matched to Mild HI | Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study. | 0 | 8 | 5 | 8 |
| EG002 | Part 2-Moderate HI | Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. | 0 | 9 | 4 | 9 |
| EG003 | Part 2-Healthy Matched to Moderate HI | Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. | 0 | 9 | 4 | 9 |
| EG004 | Part 3-Severe HI | Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study. | 1 | 8 | 4 | 8 |
| EG005 | Part 3-Healthy Matched to Severe HI | Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study. | 0 | 8 | 3 | 8 |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA Version 17.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 17.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA Version 17.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Mechanical urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA Version 17.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA Version 17.1 | Systematic Assessment |
|
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.
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Day 10 |
|
| GMR |
| 1.37 |
| 2-Sided |
| 90 |
| 0.83 |
| 2.27 |
Mild HI/Healthy Matched to Mild HI |
| Superiority or Other |
| Day 1 | GMR | 7.64 | 2-Sided | 90 | 2.74 | 21.27 | Moderate HI/Healthy Matched to Moderate HI | Superiority or Other |
| Day 10 | GMR | 5.98 | 2-Sided | 90 | 2.84 | 12.57 | Moderate HI/Healthy Matched to Moderate HI | Superiority or Other |
| Day 1 | GMR | 15.18 | 2-Sided | 90 | 6.02 | 38.25 | Severe HI/Healthy Matched to Severe HI | Superiority or Other |
| Day 10 | GMR | 13.01 | 2-Sided | 90 | 6.00 | 28.21 | Severe HI/Healthy Matched to Severe HI | Superiority or Other |
| Day 10 |
|
| GMR |
| 2.99 |
| 2-Sided |
| 90 |
| 1.31 |
| 6.82 |
Moderate HI/Healthy Matched to Moderate HI |
| Superiority or Other |
| GMR |
| 3.59 |
| 2-Sided |
| 90 |
| 1.81 |
| 7.11 |
Moderate HI/Healthy Matched to Moderate HI |
| Superiority or Other |
| GMR | 9.34 | 2-Sided | 90 | 4.98 | 17.51 | Severe HI/Healthy Matched to Severe HI | Superiority or Other |