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| Name | Class |
|---|---|
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
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The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with chronic hepatitis C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MP-424 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MP-424 (Telaprevir) | Drug | Three tablets of MP-424 250mg tablet at a time, every 8 hours, 12 weeks administration (dose in a day: 2250 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum Observed Concentration in Plasma) of MP-424 | Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57. | Date were collected at Day1 to Day85 |
| Tmax (Time of Maximum Plasma Concentration) of MP-424 | Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57. | Date were collected at Day1 to Day85 |
| AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424 | Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57. | Date were collected at Day1 to Day85 |
| Ctrough (Plasma Trough Concentration) of MP-424 | Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57. | Date were collected at Day1 to Day85 |
| t1/2 (Half Life Period) of MP-424 | Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HCV RNA Levels of MP-424 | Date were collected at Day -28, Day1 (0 (pre-dose), 2.5, 4, 8, 16 hours post-dose), Day2, Day3, Day8, Day14, Day29, Day43, Day57, Day86. Change Value was calculated as the each time point minus the baseline point which was averaged Day -28 and Day0-0hour(pre-dose)). | Day1 (2.5, 4, 8, 16 hours), Day2, Day3, Day8, Day14, Day29, Day43, Day57 and Day86 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fumitaka Suzuki, MD | Department of Hepatology, Toranomon Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toranomon Hospital | Kawasaki | Takatsu-ku | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22239508 | Result | Yamada I, Suzuki F, Kamiya N, Aoki K, Sakurai Y, Kano M, Matsui H, Kumada H. Safety, pharmacokinetics and resistant variants of telaprevir alone for 12 weeks in hepatitis C virus genotype 1b infection. J Viral Hepat. 2012 Feb;19(2):e112-9. doi: 10.1111/j.1365-2893.2011.01514.x. Epub 2011 Oct 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MP-424 | Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | MP-424 | Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir |
| 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 | Cmax (Maximum Observed Concentration in Plasma) of MP-424 | Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57. | Posted | Mean | Standard Deviation | μg / mL | Date were collected at Day1 to Day85 |
|
|
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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 | MP-424 | Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C486464 | telaprevir |
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| Date were collected at Day1 to Day85 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Tmax (Time of Maximum Plasma Concentration) of MP-424 | Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57. | Posted | Median | Full Range | hours | Date were collected at Day1 to Day85 |
|
|
|
| Primary | AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424 | Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57. | Posted | Mean | Standard Deviation | μg x h /mL | Date were collected at Day1 to Day85 |
|
|
|
| Primary | Ctrough (Plasma Trough Concentration) of MP-424 | Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57. | Posted | Mean | Standard Deviation | μg/mL | Date were collected at Day1 to Day85 |
|
|
|
| Primary | t1/2 (Half Life Period) of MP-424 | Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57. | Posted | Mean | Standard Deviation | hours | Date were collected at Day1 to Day85 |
|
|
|
| Secondary | Change in HCV RNA Levels of MP-424 | Date were collected at Day -28, Day1 (0 (pre-dose), 2.5, 4, 8, 16 hours post-dose), Day2, Day3, Day8, Day14, Day29, Day43, Day57, Day86. Change Value was calculated as the each time point minus the baseline point which was averaged Day -28 and Day0-0hour(pre-dose)). | Posted | Mean | Standard Deviation | Log IU / mL | Day1 (2.5, 4, 8, 16 hours), Day2, Day3, Day8, Day14, Day29, Day43, Day57 and Day86 |
|
|
|
| 0 |
| 10 |
| 9 |
| 10 |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 11.1 |
|
| Headache | Nervous system disorders | MedDRA 11.1 |
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| Vertigo | Ear and labyrinth disorders | MedDRA 11.1 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.1 |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.1 |
|
| Periodontitis | Gastrointestinal disorders | MedDRA 11.1 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 11.1 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 |
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| Oedema peripheral | General disorders | MedDRA 11.1 |
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| Pyrexia | General disorders | MedDRA 11.1 |
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| Malaise | General disorders | MedDRA 11.1 |
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| Thirst | General disorders | MedDRA 11.1 |
|
| Low density lipoprotein increased | Investigations | MedDRA 11.1 |
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| Blood uric acid increased | Investigations | MedDRA 11.1 |
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| Blood triglycerides increased | Investigations | MedDRA 11.1 |
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| Blood creatinine increased | Investigations | MedDRA 11.1 |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 11.1 |
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| Blood luteinising hormone increased | Investigations | MedDRA 11.1 |
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| Eosinophil percentage increased | Investigations | MedDRA 11.1 |
|
| Lymphocyte percentage decreased | Investigations | MedDRA 11.1 |
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| Blood cholesterol increased | Investigations | MedDRA 11.1 |
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| Palpitation | Cardiac disorders | MedDRA 11.1 |
|
| Conjunctivitis | Eye disorders | MedDRA 11.1 |
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| Myodesopsia | Eye disorders | MedDRA 11.1 |
|
| Ginginal swelling | Gastrointestinal disorders | MedDRA 11.1 |
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| Blood gonadotropin increased | Investigations | MedDRA 11.1 |
|
| Differential white blood cell count abnormal | Investigations | MedDRA 11.1 |
|
| Facial palsy | Nervous system disorders | MedDRA 11.1 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 |
|
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| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Day 1_16h (10 cases) |
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| Day 2 before dosing (10 cases) |
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| Day 3 (10 cases) |
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| Day 8 (10 cases) |
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| Day 14 (10 cases) |
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| Day 29 (10 cases) |
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| Day 43 (10 cases) |
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| Day 57 (5 cases) |
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| Day 86 (3 cases) |
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