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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-002697-30 | EudraCT Number |
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The objective of this study is to evaluate the safety and tolerability of single rising doses of ASP2151 under fasted condition in healthy male subjects.
The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under fasted versus fed conditions in healthy male subjects.
Study will be divided into two parts. Part 1 will evaluate the safety and tolerability of ASP2151 single rising doses in groups A-H in fasted condition and to determine the maximum tolerable dose (MTD) if possible.
Part 2 will evaluate the effect of fasted versus fed conditions on the safety, tolerability and PK of a single dose of ASP2151 in two treatment cycles. The wash-out period between the two treatment cycles will be at least 5 days and not shorter than five times the average elimination half-life of ASP2151, as determined in part 1 of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: ASP2151 Single Ascending Dose Group A (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group A on day 1 |
|
| Part 1: ASP2151 Single Ascending Dose Group B (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group B on day 1 |
|
| Part 1: ASP2151 Single Ascending Dose Group C (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group C on day 1 |
|
| Part 1: ASP2151 Single Ascending Dose Group D (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group D on day 1 |
|
| Part 1: ASP2151 Single Ascending Dose Group E (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group E on day 1 |
|
| Part 1: ASP2151 Single Ascending Dose Group F (Fasting) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP2151 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessed by nature, frequency, and severity of Adverse Events (AEs) | For Part 1 and Part 2 | Up to Day 15 of each treatment period |
| Safety assessed by 12- lead electrocardiogram (ECG) | For Part 1 and Part 2 | Up to Day 15 of each treatment period |
| Safety assessed by vital sign measurement: blood pressure | For Part 1 and Part 2 includes systolic and blood diastolic pressure | Up to Day 15 of each treatment period |
| Safety assessed by vital sign measurement: pulse rate | For Part 1 and Part 2 | Up to Day 15 of each treatment period |
| Safety assessed by laboratory test: biochemical | For Part 1 and Part 2 | Up to Day 15 of each treatment period |
| Safety assessed by laboratory test: hematological | For Part 1 and Part 2 | Up to Day 15 of each treatment period |
| Safety assessed by laboratory test: serology | For Part 1 and Part 2 | Up to Day 15 of each treatment period |
| Safety assessed by laboratory test: urinalysis | For Part 1 and Part 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of ASP2151 in plasma: AUC0-inf | For Part 1 and 2. AUC0-inf: Area under the concentration time curve from the time of dosing extrapolated to time infinity | Up to 48 hours in each treatment period |
| Pharmacokinetics of ASP2151 in plasma: t1/2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Clinical Pharmacology & Exploratory Dev. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site FR1717 | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29134426 | Derived | Kusawake T, Keirns JJ, Kowalski D, den Adel M, Groenendaal-van de Meent D, Takada A, Ohtsu Y, Katashima M. Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies. Adv Ther. 2017 Dec;34(12):2625-2637. doi: 10.1007/s12325-017-0642-4. Epub 2017 Nov 13. |
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| ID | Term |
|---|---|
| D006558 | Herpes Genitalis |
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C568714 | ASP2151 |
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| Experimental |
Participants will receive single dose of ASP2151 assigned to Group F on day 1 |
|
| Part 1: Placebo Single Ascending Dose (Fasting) | Placebo Comparator | Participants will receive single dose of matching placebo on day 1 |
|
| Part 2: ASP2151 (Fasting) | Experimental | Participants will receive a single dose of ASP2151 under fasted conditions on day 1 in the first treatment period (period 1). Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2) |
|
| Part 2: ASP2151 (Fed) | Experimental | Participants will receive a single dose of ASP2151 under fed conditions on day 1 in the first treatment period (period 1). Following a wash-out period of at least five days, the treatment will be repeated in the reverse orientation (period 2) |
|
| Part 1: ASP2151 Single Ascending Dose Group G (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group G on day 1 |
|
| Part 1: ASP2151 Single Ascending Dose Group H (Fasting) | Experimental | Participants will receive single dose of ASP2151 assigned to Group H on day 1 |
|
| Placebo | Drug | Oral |
|
| Up to Day 15 of each treatment period |
| Safety assessed by physical exam: body weight | For Part 1 and Part 2 | Up to Day 15 of each treatment period |
| Safety assessed by physical exam: height | For Part 1 and Part 2 | Up to Day 15 of each treatment period |
| Safety assessed by physical exam: body mass index (BMI) | For Part 1 and Part 2 | Up to Day 15 of each treatment period |
For Part 1 and 2. t1/2: Apparent terminal elimination half-life |
| Up to 48 hours in each treatment period |
| Pharmacokinetics of ASP2151 in plasma: Cmax | For Part 1 and 2. Cmax: Maximum concentration | Up to 48 hours in each treatment period |
| Pharmacokinetics of ASP2151 in plasma: tmax | For Part 1 and 2. tmax: The time after dosing when Cmax occurs | Up to 48 hours in each treatment period |
| Pharmacokinetics of ASP2151 in plasma: CL/F | For Part 1 and 2. CL/F: Oral clearance | Up to 48 hours in each treatment period |
| Pharmacokinetics of ASP2151 in plasma: Vz/F | For Part 1 and 2. Vz/F: Apparent volume of distribution | Up to 48 hours in each treatment period |
| Pharmacokinetics of ASP2151 in plasma: AUClast | For Part 1 and 2. AUClast: Area under the plasma concentration time curve from time of dosing up to the last quantifiable sample | Up to 48 hours in each treatment period |
| Pharmacokinetics of ASP2151 in plasma: tlag | For Part 1 and 2. tlag: Absorption lag time | Up to 48 hours in each treatment period |
| Pharmacokinetics of ASP2151 in urine: Aelast | For Part 1 and 2. Aelast: Amount excreted unchanged in urine from time of dosing up to the last quantifiable sample | Up to 48 hours in each treatment period |
| Pharmacokinetics of ASP2151 in urine: Ae0-inf | For Part 1 and 2. Ae0-inf: Amount excreted unchanged in urine from time of dosing extrapolated to infinity | Up to 48 hours in each treatment period |
| Pharmacokinetics of ASP2151 in urine: Ae% | For Part 1 and 2. Ae%: Percent of ASP2151 amount excreted in urine | Up to 48 hours in each treatment period |
| Pharmacokinetics of ASP2151 in urine: CLr | For Part 1 and 2. CLr: Renal clearance | Up to 48 hours in each treatment period |
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D000073618 | Varicella Zoster Virus Infection |