Healthy
Conditions
Keywords
HSV, Herpes, volunteers, drug-drug interaction, transplant
Brief summary
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.
Interventions
DRUGASP2151 400mg + 100mg ciclosporin
DRUGASP2151 1200mg + 100mg ciclosporin
Sponsors
Maruho Europe Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* A body mass index (Quetelet index) in the range 18.0-30.9 kg/m2. * Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial. * Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate. * Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).
Exclusion criteria
* Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer. * Any of the following liver function tests higher than 1.5 times the ULN at the screening visit: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), bilirubin, gamma glutamyl transpeptidase (gamma-GT). * Platelet counts outside normal limits. * Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous. * Clinically significant impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness. * Receipt of a live vaccine in the 3 months before the first dose of study medication, or planned immunisation with a live vaccine during the study. * Evidence of any significant bacterial, viral, fungal or parasitic infection during the 4 weeks before dosing (minor fungal nail infections will not be regarded as significant); minor infection (eg common cold) not requiring anti-infective treatment during the 2 weeks before dosing. * History of bleeding diathesis. * Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines. * Presence or history of severe adverse reaction to any drug, history of multiple drug allergies (multiple defined as \>3), or sensitivity to trial medication. * Use, during the 28 days before the first dose of trial medication, of any prescription medicine, or any other medicine or herbal remedy (such as St John's wort) known to interfere with the CYP3A4 metabolic pathway (unless judged as not clinical significant by the investigator and sponsor). See Appendix 1 for common CYP3A4 interactors/substrates. * Use, during the 7 days before the first dose of trial medication, of any over-the-counter medicine, with the exception of paracetamol (acetaminophen). * Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months. * Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor. * Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly or more than 5 cigarettes daily. * Evidence of drug abuse on urine testing. * Positive test for hepatitis B antigen (HBsAg); or positive test for hepatitis B core antibody (HBcAb). * Positive test for hepatitis C, HIV1, HIV2, or active and latent tuberculosis. * Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40-100 beats/min. * Possibility that the volunteer will not cooperate with the requirements of the protocol. * Objection by General Practitioner (GP) to volunteer entering trial.
Design outcomes
Primary
| Measure | 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious and Non-Serious Adverse Events | Up to 31 days after the Day 7 dose of ASP2151 | Refer to the result of adverse event. |
Other
| Measure | 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Time of Peak Concentration (Tmax) 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. |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| ASP2151 400mg ASP2151 400mg followed by ASP2151 400mg + 100mg ciclosporin first, then ASP and 1200mg mg followed by ASP2151 1200mg + 100mg ciclosporin | 13 |
| ASP2151 1200mg ASP2151 1200mg followed by ASP2151 1200mg + 100mg ciclosporin first, then ASP and 400mg mg followed by ASP2151 400mg + 100mg ciclosporin | 13 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout (2 Weeks) | Adverse Event | 0 | 1 |
| Washout (2 Weeks) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | ASP2151 400mg | ASP2151 1200mg |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 13 Participants | 13 Participants |
| Age, Continuous | 32.7 year STANDARD_DEVIATION 7.2 | 33.6 year STANDARD_DEVIATION 7.4 | 31.8 year STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 13 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 13 Participants | 13 Participants |
| Region of Enrollment United Kingdom | 26 Participants | 13 Participants | 13 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 26 Participants | 13 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 2 / 24 | 5 / 24 | 10 / 24 | 3 / 24 | 3 / 24 | 11 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASP2151 400mg Alone | Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma | 17.745 L/h | Standard Deviation 4.6288 |
| ASP2151 400mg With Ciclosporin | Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma | 21.917 L/h | Standard Deviation 5.9182 |
| ASP2151 1200mg Alone | Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma | 25.695 L/h | Standard Deviation 6.3004 |
| ASP2151 1200mg With Ciclosporin | Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma | 32.699 L/h | Standard Deviation 9.3284 |
Primary
Apparent Volume of Distribution (Vd/F) of ASP2151
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASP2151 400mg Alone | Apparent Volume of Distribution (Vd/F) of ASP2151 | 196.9 L | Standard Deviation 45.72 |
| ASP2151 400mg With Ciclosporin | Apparent Volume of Distribution (Vd/F) of ASP2151 | 269.6 L | Standard Deviation 69.57 |
| ASP2151 1200mg Alone | Apparent Volume of Distribution (Vd/F) of ASP2151 | 276.5 L | Standard Deviation 69.55 |
| ASP2151 1200mg With Ciclosporin | Apparent Volume of Distribution (Vd/F) of ASP2151 | 395.3 L | Standard Deviation 118.47 |
Primary
Area Under the Curve (AUC) of ASP2151
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ASP2151 400mg Alone | Area Under the Curve (AUC) of ASP2151 | 23307.4 h*ng/mL | Geometric Coefficient of Variation 27.1 |
| ASP2151 400mg With Ciclosporin | Area Under the Curve (AUC) of ASP2151 | 19013.5 h*ng/mL | Geometric Coefficient of Variation 31.4 |
| ASP2151 1200mg Alone | Area Under the Curve (AUC) of ASP2151 | 48051.2 h*ng/mL | Geometric Coefficient of Variation 25 |
| ASP2151 1200mg With Ciclosporin | Area Under the Curve (AUC) of ASP2151 | 37940.8 h*ng/mL | Geometric Coefficient of Variation 25.9 |
Primary
Half-Life (t1/2) of ASP2151
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ASP2151 400mg Alone | Half-Life (t1/2) of ASP2151 | 7.755 h | Geometric Coefficient of Variation 12.1 |
| ASP2151 400mg With Ciclosporin | Half-Life (t1/2) of ASP2151 | 8.593 h | Geometric Coefficient of Variation 16.4 |
| ASP2151 1200mg Alone | Half-Life (t1/2) of ASP2151 | 7.457 h | Geometric Coefficient of Variation 13.2 |
| ASP2151 1200mg With Ciclosporin | Half-Life (t1/2) of ASP2151 | 8.326 h | Geometric Coefficient of Variation 14.1 |
Primary
Peak Plasma Concentration (Cmax) of ASP2151
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ASP2151 400mg Alone | Peak Plasma Concentration (Cmax) of ASP2151 | 1818.0 ng/mL | Geometric Coefficient of Variation 26.1 |
| ASP2151 400mg With Ciclosporin | Peak Plasma Concentration (Cmax) of ASP2151 | 1202.3 ng/mL | Geometric Coefficient of Variation 31.5 |
| ASP2151 1200mg Alone | Peak Plasma Concentration (Cmax) of ASP2151 | 3573.1 ng/mL | Geometric Coefficient of Variation 26.1 |
| ASP2151 1200mg With Ciclosporin | Peak Plasma Concentration (Cmax) of ASP2151 | 2452.1 ng/mL | Geometric Coefficient of Variation 31.4 |
Primary
Time of Peak Concentration (Tmax) of ASP2151
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASP2151 400mg Alone | Time of Peak Concentration (Tmax) of ASP2151 | 3.00 h |
| ASP2151 400mg With Ciclosporin | Time of Peak Concentration (Tmax) of ASP2151 | 4.00 h |
| ASP2151 1200mg Alone | Time of Peak Concentration (Tmax) of ASP2151 | 3.00 h |
| ASP2151 1200mg With Ciclosporin | Time of Peak Concentration (Tmax) of ASP2151 | 4.00 h |
Secondary
Number of Participants With Serious and Non-Serious Adverse Events
Refer to the result of adverse event.
Time frame: Up to 31 days after the Day 7 dose of ASP2151
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ASP2151 400mg Alone | Number of Participants With Serious and Non-Serious Adverse Events | Non-serious adverse event | 15 participants |
| ASP2151 400mg Alone | Number of Participants With Serious and Non-Serious Adverse Events | serious adverse event | 0 participants |
| ASP2151 400mg With Ciclosporin | Number of Participants With Serious and Non-Serious Adverse Events | Non-serious adverse event | 15 participants |
| ASP2151 400mg With Ciclosporin | Number of Participants With Serious and Non-Serious Adverse Events | serious adverse event | 0 participants |
Other Pre-specified
Area Under the Curve (AUC) of AS195588-00
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ASP2151 400mg Alone | Area Under the Curve (AUC) of AS195588-00 | 2614.4 h*ng/mL | Geometric Coefficient of Variation 27.4 |
| ASP2151 400mg With Ciclosporin | Area Under the Curve (AUC) of AS195588-00 | 2441.3 h*ng/mL | Geometric Coefficient of Variation 20.2 |
| ASP2151 1200mg Alone | Area Under the Curve (AUC) of AS195588-00 | 6147.4 h*ng/mL | Geometric Coefficient of Variation 29.7 |
| ASP2151 1200mg With Ciclosporin | Area Under the Curve (AUC) of AS195588-00 | 5584.5 h*ng/mL | Geometric Coefficient of Variation 31 |
Other Pre-specified
Area Under the Curve (AUC) of Ciclosporin
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ASP2151 400mg Alone | Area Under the Curve (AUC) of Ciclosporin | 1944.3 h*ng/mL | Geometric Coefficient of Variation 19.7 |
| ASP2151 400mg With Ciclosporin | Area Under the Curve (AUC) of Ciclosporin | 2011.0 h*ng/mL | Geometric Coefficient of Variation 22.1 |
| ASP2151 1200mg Alone | Area Under the Curve (AUC) of Ciclosporin | 1894.2 h*ng/mL | Geometric Coefficient of Variation 22.9 |
| ASP2151 1200mg With Ciclosporin | Area Under the Curve (AUC) of Ciclosporin | 1888.2 h*ng/mL | Geometric Coefficient of Variation 19.6 |
Other Pre-specified
Half-Life (t1/2) of AS195588-00
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ASP2151 400mg Alone | Half-Life (t1/2) of AS195588-00 | 8.59 h | Geometric Coefficient of Variation 15.3 |
| ASP2151 400mg With Ciclosporin | Half-Life (t1/2) of AS195588-00 | 9.62 h | Geometric Coefficient of Variation 18.4 |
| ASP2151 1200mg Alone | Half-Life (t1/2) of AS195588-00 | 8.25 h | Geometric Coefficient of Variation 14.3 |
| ASP2151 1200mg With Ciclosporin | Half-Life (t1/2) of AS195588-00 | 9.02 h | Geometric Coefficient of Variation 16.4 |
Other Pre-specified
Peak Plasma Concentration (Cmax) of ASP1955888-00
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ASP2151 400mg Alone | Peak Plasma Concentration (Cmax) of ASP1955888-00 | 173.0 ng/mL | Geometric Coefficient of Variation 35.2 |
| ASP2151 400mg With Ciclosporin | Peak Plasma Concentration (Cmax) of ASP1955888-00 | 132.6 ng/mL | Geometric Coefficient of Variation 28.1 |
| ASP2151 1200mg Alone | Peak Plasma Concentration (Cmax) of ASP1955888-00 | 387.3 ng/mL | Geometric Coefficient of Variation 38.1 |
| ASP2151 1200mg With Ciclosporin | Peak Plasma Concentration (Cmax) of ASP1955888-00 | 307.2 ng/mL | Geometric Coefficient of Variation 42.7 |
Other Pre-specified
Peak Plasma Concentration (Cmax) of Ciclosporin
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ASP2151 400mg Alone | Peak Plasma Concentration (Cmax) of Ciclosporin | 491.0 ng/mL | Geometric Coefficient of Variation 18.6 |
| ASP2151 400mg With Ciclosporin | Peak Plasma Concentration (Cmax) of Ciclosporin | 482.3 ng/mL | Geometric Coefficient of Variation 18.3 |
| ASP2151 1200mg Alone | Peak Plasma Concentration (Cmax) of Ciclosporin | 467.0 ng/mL | Geometric Coefficient of Variation 23.7 |
| ASP2151 1200mg With Ciclosporin | Peak Plasma Concentration (Cmax) of Ciclosporin | 440.0 ng/mL | Geometric Coefficient of Variation 18.6 |
Other Pre-specified
Time of Peak Concentration (Tmax) of AS195588-00
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASP2151 400mg Alone | Time of Peak Concentration (Tmax) of AS195588-00 | 3.03 h |
| ASP2151 400mg With Ciclosporin | Time of Peak Concentration (Tmax) of AS195588-00 | 4.00 h |
| ASP2151 1200mg Alone | Time of Peak Concentration (Tmax) of AS195588-00 | 3.53 h |
| ASP2151 1200mg With Ciclosporin | Time of Peak Concentration (Tmax) of AS195588-00 | 4.00 h |
Other Pre-specified
Time of Peak Concentration (Tmax) of Ciclosporin
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASP2151 400mg Alone | Time of Peak Concentration (Tmax) of Ciclosporin | 2.00 h |
| ASP2151 400mg With Ciclosporin | Time of Peak Concentration (Tmax) of Ciclosporin | 2.00 h |
| ASP2151 1200mg Alone | Time of Peak Concentration (Tmax) of Ciclosporin | 2.00 h |
| ASP2151 1200mg With Ciclosporin | Time of Peak Concentration (Tmax) of Ciclosporin | 2.00 h |