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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002174-37 | EudraCT Number |
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ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to contracting other infections because of their compromised immune system. As HIV patients will be taking drugs to treat the virus this study aims to see if ASP2151 would interact with one of the drugs that is commonly prescribed to HIV patients (ritonavir).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400mg ASP2151 | Other | 400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir |
|
| 1200mg ASP2151 | Other | 1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP2151 | Drug |
| ||
| ritonavir |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of ASP2151 | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention | |
| Time of Peak Concentration (Tmax) of ASP2151 | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention | |
| Area Under the Curve (AUC) of ASP2151 | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention | |
| Half-Life (t1/2) of ASP2151 | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention | |
| Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention | |
| Apparent Volume of Distribution (Vd/F) of ASP2151 | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and Non-Serious Adverse Events | Refer to the result of adverse event. | Up to 31 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of ASP1955888-00 | ASP1955888-00 is a metabolite of the study drug (ASP2151) | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
| Time of Peak Concentration (Tmax) of ASP1955888-00 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research Ltd | London | NW10 7EW | United Kingdom |
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Participants took part in the study at one investigative site in United Kingdom from 05-September 2014 to 04-December 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | 400mg ASP2151 | ASP2151 400mg alone followed by ASP2151 400mg + 600 mg ritonavir, or vice versa. |
| FG001 | 1200mg ASP2151 | ASP2151 1200mg alone followed by ASP2151 1200mg + 600 mg ritonavir, or vice versa. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 400mg ASP2151 | ASP2151 400mg alone followed by ASP2151 400mg + 600 mg ritonavir, or vice versa. |
| BG001 | 1200mg ASP2151 | ASP2151 1200mg alone followed by ASP2151 1200mg + 600 mg ritonavir, or vice versa. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Peak Plasma Concentration (Cmax) of ASP2151 | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
Up to 31 days after the final dose
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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 | 400 mg ASP2151 Alone | 400 mg ASP2151 alone | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA/17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maruho Co.,Ltd. Kyoto R&D Center | Clinical Development Dept. | +81-75-325-3255 | ctinfo@mii.maruho.co.jp |
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| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C568714 | ASP2151 |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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|
|
ASP1955888-00 is a metabolite of the study drug (ASP2151) |
| Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
| Area Under the Curve (AUC) of ASP1955888-00 | ASP1955888-00 is a metabolite of the study drug (ASP2151) | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
| Half-life (t1/2) of ASP1955888-00 | ASP1955888-00 is a metabolite of the study drug (ASP2151) | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
| Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00 | ASP1955888-00 is a metabolite of the study drug (ASP2151) | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
| Apparent Volume of Distribution (Vd/F) of ASP1955888-00 | ASP1955888-00 is a metabolite of the study drug (ASP2151) | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG003 | 1200mg ASP2151 With Ritonavir | 1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir ASP2151 ritonavir |
|
|
| Primary | Time of Peak Concentration (Tmax) of ASP2151 | Posted | Median | Full Range | h | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
|
|
| Primary | Area Under the Curve (AUC) of ASP2151 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
|
|
| Primary | Half-Life (t1/2) of ASP2151 | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
|
|
| Primary | Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma | Posted | Mean | Standard Deviation | L/h | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
|
|
| Primary | Apparent Volume of Distribution (Vd/F) of ASP2151 | Posted | Mean | Standard Deviation | L | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
|
|
| Secondary | Number of Participants With Serious and Non-Serious Adverse Events | Refer to the result of adverse event. | Posted | Number | participants | Up to 31 days |
|
|
|
| Other Pre-specified | Peak Plasma Concentration (Cmax) of ASP1955888-00 | ASP1955888-00 is a metabolite of the study drug (ASP2151) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
|
|
| Other Pre-specified | Time of Peak Concentration (Tmax) of ASP1955888-00 | ASP1955888-00 is a metabolite of the study drug (ASP2151) | Posted | Median | Full Range | h | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
|
|
| Other Pre-specified | Area Under the Curve (AUC) of ASP1955888-00 | ASP1955888-00 is a metabolite of the study drug (ASP2151) | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
|
|
| Other Pre-specified | Half-life (t1/2) of ASP1955888-00 | ASP1955888-00 is a metabolite of the study drug (ASP2151) | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
|
|
| Other Pre-specified | Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00 | ASP1955888-00 is a metabolite of the study drug (ASP2151) | Posted | Mean | Standard Deviation | L/h | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
|
|
| Other Pre-specified | Apparent Volume of Distribution (Vd/F) of ASP1955888-00 | ASP1955888-00 is a metabolite of the study drug (ASP2151) | Posted | Mean | Standard Deviation | L | Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention |
|
|
|
| 24 |
| 0 |
| 24 |
| 8 |
| 24 |
| EG001 | 400 mg ASP2151 With Ritonavir | 400 mg ASP2151 with 600 mg ritonavir | 0 | 24 | 0 | 24 | 17 | 24 |
| EG002 | 1200 mg ASP2151 Alone | 1200 mg ASP2151 alone | 0 | 24 | 0 | 24 | 15 | 24 |
| EG003 | 1200 mg ASP2151 With Ritonavir | 1200 mg ASP2151 with 600 mg ritonavir | 0 | 24 | 0 | 24 | 13 | 24 |
| Dizziness | Nervous system disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA/17.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA/17.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA/17.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| joint swelling | Musculoskeletal and connective tissue disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA/17.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/17.0 | Non-systematic Assessment |
|
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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| serious adverse event |
|