Clinical trial NCT04878471: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male Participants
Official title: A Phase 1 Single Intravenous Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: ASP5354; Pharmacokinetics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous doses of ASP5354 in healthy, adult Japanese male participants.

Detailed description: This study is comprised of 3 parts. Part 1 and Part 2 will be conducted in a parallel manner while Part 3 will be conducted subsequentially. Participants will be residential for a period of 3 days/2 nights. Participants will be discharged from the clinical unit on day 2 on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit.

Eligibility criteria: Inclusion Criteria:

* 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.
* 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.
* Male participant must not donate sperm during the treatment period and for 30 days after IP administration.
* 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.
* Participant agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

* Participant has received any investigational therapy within 12 weeks prior to screening.
* Participant has any condition that makes the participant unsuitable for study participation.
* Participant has a known or suspected hypersensitivity to ASP5354 or any components of the formulation used.
* Participant has had previous exposure with ASP5354.
* 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.
* Participant has creatinine level outside normal limits on day -1. In such a case, the assessment may be repeated once.
* 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.
* 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.
* Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
* Participant has any clinically significant abnormality following the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.
* 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.
* Participant has body temperature \< 35.0ºC or \>= 37.5ºC on day -1.
* 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.
* 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).
* Participant has a history of smoking \> 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1.
* 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 \[12%\]).
* 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.
* Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1.
* Participant has had significant blood loss, donated \>= 400 mL of whole blood within 90 days, \>= 200 mL of whole blood within 30 days or donated blood components within 14 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
* Participant has a positive serology test for hepatitis B core (HBc) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and antigen or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 and syphilis at screening.
* Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 6 days
measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs)
timeFrame: Up to 6 days
measure: Number of participants with vital sign abnormalities and/or adverse events (AEs)
timeFrame: Up to 6 days
measure: Number of participants with routine 12-lead electrocardiogram (ECG) abnormalities and/or adverse events (AEs)
timeFrame: Up to 6 days
Secondary outcomes:
measure: Pharmacokinetics (PK) of ASP5354 in plasma: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
timeFrame: Up to 2 days
measure: PK of ASP5354 in plasma: Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
timeFrame: Up to 2 days
measure: PK of ASP5354 in plasma: Maximum concentration (Cmax)
timeFrame: Up to 2 days
measure: PK of ASP5354 in urine: amount of administered dose excreted from the time of dosing to the last measurable point after dosing
timeFrame: Up to 2 days
measure: PK of ASP5354 in urine: percent of administered dose excreted from the time of dosing to the last measurable point after dosing
timeFrame: Up to 2 days
measure: PK of ASP5354 in urine: Renal Clearance (CLR)
timeFrame: Up to 2 days
Other outcomes:
Locations:
city: Sumida-ku
country: Japan
facility: JP81001
state: Tokyo
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: