Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male Participants
- Conditions
- aparoscopic/Minimally Invasive Colorectal Surgery
- Registration Number
- JPRN-jRCT2071210026
- Lead Sponsor
- Raizer Jeffrey
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 12
1.Participant has a body mass index (BMI) range of 17.6 to 26.4 kg/m^2 inclusive and weighs at least 50 kg at screening.
2.Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 30 days after Investigational Product (IP) administration.
3.Male participant must not donate sperm during the treatment period and for 30 days after IP administration.
4.Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after IP administration.
5.Participant agrees not to participate in another interventional study while participating in the present study.
1.Participant has received any investigational therapy within 12 weeks prior to screening.
2.Participant has any condition that makes the participant unsuitable for study participation.
3.Participant has a known or suspected hypersensitivity to ASP5354 or any components of the formulation used.
4.Participant has had previous exposure with ASP5354.
5.Participant has any of the liver function tests (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and total bilirubin [TBL]) above the upper limit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.
6.Participant has creatinine level outside normal limits on day -1. In such a case, the assessment may be repeated once.
7.Participant has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to IP administration.
8.Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
9.Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
10.Participant has any clinically significant abnormality following the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.
11.Participant has a mean pulse <40 or >100 bpm; mean systolic blood pressure (SBP) < 90 or > 140 mmHg; mean diastolic blood pressure (DBP) < 40 or > 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, one additional triplicate may be taken.
12.Participant has body temperature < 35.0 degree or >= 37.5 degree on day -1.
13.Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of > 430 msec on day -1. If the mean QTcF exceeds the limits above, one additional triplicate ECG may be taken.
14.Participant has used any prescribed or nonprescribed drugs (including vitamins, oral contraceptives or hormone replacement therapy (HRT) and natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to IP administration, except for occasional use of acetaminophen (up to 2 g/day) and topical dermatological products (including corticosteroid products).
15.Participant has a history of smoking > 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1.
16.Participant has a history of consuming > 16 units of alcohol per week within 3 months prior to day -1 (note: 1 unit = 10 g pure alcohol, = 250 mL of beer [5%], 35 mL of spirits [35%] or 100 mL of wine [12%]).
17.Participant has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or morphine and phencyclidines) within 3 months prior to day -1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and morphine, phencyclidines) at screening or on day -1.
18.Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months pr
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method