Status:
COMPLETED
A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954
Lead Sponsor:
Takeda
Conditions:
Hepatic Impairment
Healthy Volunteers
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of varying degrees of hepatic function on the single dose PK of IV TAK-954.
Detailed Description
The drug being tested in this study is called TAK-954. This study will evaluate the safety and tolerability of single intravenous doses of TAK-954 in participants with varying degrees of hepatic funct...
Eligibility Criteria
Inclusion
- Male and female participants (non-childbearing potential), with a body mass index (BMI) between 18 to 35 kilogram per square meter (kg/m\^2) (All participants).
- Participants with hepatic impairment who are medically stable as determined by the investigator, based on medical history and clinical evaluations including physical examinations, clinical laboratory tests, vital sign measurements, and 12-lead ECGs performed at the Screening Visit and at check-in on Day -1 (Group 1 to 3).
- Healthy participants (Group 4).
Exclusion
- Participants who have:
- A history of hepatic carcinoma, hepatorenal syndrome, or presence of a liver mass by ultrasound, CT or MRI, or acute liver disease caused by an infection or drug toxicity (Group 1 to 3).
- Have severe hepatic encephalopathy (\[greater than\] \> Grade II Portal Systemic Encephalopathy Score) (Group 1 to 3).
- Surgical porto-systemic shunts, including transjugular intrahepatic portosystemic shunt (Group 1 to 3).
- A history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to trial entry (Group 1 to 3).
- Bilirubin levels above 5 times the upper limit of normal (ULN) at screening or Day -1 for Groups 1 and 2, there is no limit for Group 3.
- Severe/advanced ascites and/or pleural effusion which requires emptying and albumin supplementation, as judged by the investigator (Group 1 to 3).
- Renal creatinine clearance (CLcr) less than or equal to (\<=) 50 milliliter per minute (mL/min), calculated using the Cockcroft-Gault equation from the serum creatinine measurement taken at screening (Group 1 to 3).
- Who have a history of clinically significant endocrine, gastrointestinal (GI) (including motility disorder and intestinal obstruction), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases will be excluded from the trial (Group 4).
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03277274
Start Date
November 9 2017
End Date
September 10 2018
Last Update
September 25 2019
Active Locations (2)
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1
PRA CZ, s.r.o
Prague, Prague, Czechia, 170 00
2
Summit Center of Clinical Research
Bratislava, Slovakia, 83101