JPRN-jRCT2031220304
Completed
Phase 1
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ASP5354 in Participants with Renal Impairment Compared to Healthy Participants with Normal Renal Function
Gabriel P. Haas0 sites28 target enrollmentAugust 31, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Gabriel P. Haas
- Enrollment
- 28
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant has a BMI range of 17\.6 to 30\.0 kg/m^2 inclusive and weighs at least 50 kg for male participants and 40 kg for female participants at screening.
- •\- Female participant is not pregnant and at least 1 of the following conditions apply:
- •o Not a woman of child\-bearing potential (WOCBP)
- •o WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after study intervention administration.
- •\- Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after study intervention administration.
- •\- Female participant must not donate ova starting at study intervention administration and throughout the study period and for 30 days after study intervention administration.
- •\- Male participant with female partner(s) of childbearing potential (including breastfeeding partner\[s]) must agree to use contraception throughout the treatment period and for 30 days after study intervention administration.
- •\- Male participant must not donate sperm during the treatment period and for 30 days after study intervention 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 study intervention 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 28 days or 5 half\-lives whichever is longer, prior to screening.
- •\- Participant has any condition which makes the participant unsuitable for study participation.
- •\- Participant has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
- •\- Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
- •\- 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]) \>\= 1\.5 x upper limit of normal \[ULN] 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 study intervention administration.
- •\- 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 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 grams pure alcohol, 250 ml of beer \[5%], 35 milliliters \[ml] of spirits \[35%] or 100 ml of wine \[12%]) or the participant tests positive for alcohol at screening or on day \-1\.
Outcomes
Primary Outcomes
Not specified
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