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ASP2151 is an experimental treatment for herpes. Patients undergoing organ and tissue transplantation may be prescribed ciclosporin to suppress their immune system to give the transplant an increased chance of not being rejected. A patient with a compromised immune system is more susceptible to infections such as herpes, which will require treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP2151 400mg | Other | ASP2151 400mg + 100mg ciclosporin |
|
| ASP2151 1200mg | Other | ASP2151 1200mg + 100mg ciclosporin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP2151 400mg + 100mg ciclosporin | Drug |
| ||
| ASP2151 1200mg + 100mg ciclosporin |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of ASP2151 | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. | |
| Time of Peak Concentration (Tmax) of ASP2151 | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. | |
| Area Under the Curve (AUC) of ASP2151 | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. | |
| Half-Life (t1/2) of ASP2151 | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. | |
| Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. | |
| Apparent Volume of Distribution (Vd/F) of ASP2151 | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
| 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 after the Day 7 dose of ASP2151 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of ASP1955888-00 | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. | |
| Time of Peak Concentration (Tmax) of AS195588-00 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research Ltd | London | NW10 7EW | United Kingdom |
Participants received a single dose of 400mg or 1200mg ASP2151 on Days 1 and 7, 100 mg ciclosporin twice daily on Days 3-9, and once in the morning of Day 10. Two participants were withdrawn during the washout period, in the second intervention, another participants were replaced.
Participants took part in the study at one investigative site in United Kingdom from 06-October 2014 to 10-February 2015
Each participant was randomised to 2 groups. One group was received ASP 400mg in first intervention and 1200mg in other group. There was a washout of at least 2 weeks between the interventions.
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| ID | Title | Description |
|---|---|---|
| FG000 | ASP2151 400mg | "ASP2151 400mg followed by ASP2151 400mg + 100mg ciclosporin" first, then "ASP and 1200mg mg followed by ASP2151 1200mg + 100mg ciclosporin" |
| FG001 | ASP2151 1200mg | "ASP2151 1200mg followed by ASP2151 1200mg + 100mg ciclosporin" first, then "ASP and 400mg mg followed by ASP2151 400mg + 100mg ciclosporin" |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention(2 Weeks) |
| ||||||||||||||||
| Washout (2 Weeks) |
| ||||||||||||||||
| Second Intervention(2 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ASP2151 400mg | "ASP2151 400mg followed by ASP2151 400mg + 100mg ciclosporin" first, then "ASP and 1200mg mg followed by ASP2151 1200mg + 100mg ciclosporin" |
| BG001 | ASP2151 1200mg |
| 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 | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
|
14 days
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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 | ASP2151(400mg) Alone | Participants who administered ASP2151 alone during the treatment session 1(ASP2151 400mg) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinitis | Infections and infestations | MedDRA/ | 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 |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Drug |
|
| prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
| Area Under the Curve (AUC) of AS195588-00 | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
| Half-Life (t1/2) of AS195588-00 | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
| Peak Plasma Concentration (Cmax) of Ciclosporin | Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7. |
| Time of Peak Concentration (Tmax) of Ciclosporin | Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7. |
| Area Under the Curve (AUC) of Ciclosporin | Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7. |
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
"ASP2151 1200mg followed by ASP2151 1200mg + 100mg ciclosporin" first, then "ASP and 400mg mg followed by ASP2151 400mg + 100mg ciclosporin"
| 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 | ASP2151 1200mg With Ciclosporin | ASP2151 1200mg + 100mg ciclosporin ASP2151 1200mg + 100mg ciclosporin |
|
|
| Primary | Time of Peak Concentration (Tmax) of ASP2151 | Posted | Median | Full Range | h | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
|
|
|
| Primary | Area Under the Curve (AUC) of ASP2151 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
|
|
|
| Primary | Half-Life (t1/2) of ASP2151 | Posted | Geometric Mean | Geometric Coefficient of Variation | h | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
|
|
|
| Primary | Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma | Posted | Mean | Standard Deviation | L/h | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
|
|
|
| Primary | Apparent Volume of Distribution (Vd/F) of ASP2151 | Posted | Mean | Standard Deviation | L | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
|
|
|
| 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 after the Day 7 dose of ASP2151 |
|
|
|
| Other Pre-specified | Peak Plasma Concentration (Cmax) of ASP1955888-00 | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
|
|
|
| Other Pre-specified | Time of Peak Concentration (Tmax) of AS195588-00 | Posted | Median | Full Range | h | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
|
|
|
| Other Pre-specified | Area Under the Curve (AUC) of AS195588-00 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
|
|
|
| Other Pre-specified | Half-Life (t1/2) of AS195588-00 | Posted | Geometric Mean | Geometric Coefficient of Variation | h | prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7. |
|
|
|
| Other Pre-specified | Peak Plasma Concentration (Cmax) of Ciclosporin | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7. |
|
|
|
| Other Pre-specified | Time of Peak Concentration (Tmax) of Ciclosporin | Posted | Median | Full Range | h | Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7. |
|
|
|
| Other Pre-specified | Area Under the Curve (AUC) of Ciclosporin | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7. |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | Ciclosporin After ASP2151(400mg) | Participants who administered ciclosporin alone during the treatment session 1(ASP2151 400mg) | 0 | 24 | 0 | 24 | 5 | 24 |
| EG002 | Ciclosporin With ASP2151(400mg) | Participants who coadministered ciclosporin and ASP2151during the treatment session 1(ASP2151 400mg) | 0 | 24 | 0 | 24 | 10 | 24 |
| EG003 | ASP2151(1200mg) Alone | Participants who administered ASP2151 alone during the treatment session 1(ASP2151 1200mg) | 0 | 24 | 0 | 24 | 3 | 24 |
| EG004 | Ciclosporin After ASP2151(1200mg) | Participants who administered ciclosporin alone during the treatment session 1(ASP2151 1200mg) | 0 | 24 | 0 | 24 | 3 | 24 |
| EG005 | Ciclosporin With ASP2151(1200mg) | Participants who coadministered ciclosporin and ASP2151during the treatment session 1(ASP2151 1200mg) | 0 | 24 | 0 | 24 | 11 | 24 |
| Nasopharyngitis | Infections and infestations | MedDRA/ | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA/ | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA/ | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA/ | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA/ | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA/ | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA/ | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA/ | Non-systematic Assessment |
|
| Influenza-like illness | General disorders | MedDRA/ | Non-systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA/ | Non-systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA/ | Non-systematic Assessment |
|
| Axillary pain | General disorders | MedDRA/ | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/ | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/ | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA/ | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/ | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA/ | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA/ | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/ | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA/ | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA/ | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA/ | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA/ | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA/ | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA/ | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA/ | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA/ | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/ | Non-systematic Assessment |
|
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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |