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Trial record 64 of 1645 for:    Slovakia

A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954

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ClinicalTrials.gov Identifier: NCT03277274
Recruitment Status : Completed
First Posted : September 11, 2017
Results First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Healthy Volunteers Drug: TAK-954 Phase 1

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 function.

The study will enroll approximately up to 32 participants. Participants will be enrolled in one of the 4 treatment groups based on their degree of hepatic impairment which will be determined based on Child-Pugh Score as follow:

  • Group 1 TAK-954 0.2 mg: Mild Hepatic Impairment (Child Pugh Class A)
  • Group 2 TAK-954 0.2 mg: Moderate Hepatic Impairment (Child Pugh Class B)
  • Group 3 TAK-954 0.2 mg: Severe Hepatic Impairment (Child Pugh Class C)
  • Group 4 TAK-954 0.2 mg: Healthy Participants

The Child-Pugh classification will assess the severity of 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy grade) on a scale of 1 (none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe) where higher score indicates more severity.

All participants will receive a single dose of TAK-954 0.2 mg on Day 1.

This study may have a full study design, where Group 1 to Group 4 will enroll approximately 8 participants in each group or a reduced study design, where no participants will be enrolled in Group 1 and approximately 8 participants will be enrolled in Group 2 to Group 4.

This multi-center trial will be conducted in Czech Republic and Slovakia. The overall time to participate in this study is approximately 7 weeks. Participants will remain confined to the clinic for 4 days, with 2 further out-patient visits, and will make a final visit to the clinic 10-14 days after receiving their last dose of TAK-954 for a follow-up assessment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Non-Randomized, Open-Label Trial to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics of Intravenous TAK-954
Actual Study Start Date : November 9, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 10, 2018

Arm Intervention/treatment
Experimental: Group 1 Mild Hepatic Impairment: TAK-954 0.2 mg
TAK-954 0.2 milligram (mg), intravenous, administered as 60-minute infusion, once on Day 1.
Drug: TAK-954
TAK-954 intravenous infusion.

Experimental: Group 2 Moderate Hepatic Impairment: TAK-954 0.2 mg
TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1.
Drug: TAK-954
TAK-954 intravenous infusion.

Experimental: Group 3 Severe Hepatic Impairment: TAK-954 0.2 mg
TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1.
Drug: TAK-954
TAK-954 intravenous infusion.

Experimental: Group 4 Healthy Participants: TAK-954 0.2 mg
TAK-954 0.2 mg, intravenous, administered as 60-minute infusion, once on Day 1.
Drug: TAK-954
TAK-954 intravenous infusion.




Primary Outcome Measures :
  1. Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free) [ Time Frame: Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion ]
  2. AUClast: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Total and Free) [ Time Frame: Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion ]
  3. AUC∞: Area Under the Concentration-time Curve From Time 0 to Infinity for TAK-954 (Total and Free) [ Time Frame: Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion ]

Secondary Outcome Measures :
  1. Number of Participants With Clinically Significant Physical Examination Findings [ Time Frame: Up to 14 days after the last dose of study drug (Day 15) ]
  2. Number of Participants With Markedly Abnormal Electrocardiograms (ECGs) [ Time Frame: Up to 14 days after the last dose of study drug (Day 15) ]
  3. Number of Participants With Markedly Abnormal Values of Vital Signs [ Time Frame: Up to 14 days after the last dose of study drug (Day 15) ]
  4. Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values [ Time Frame: Up to 14 days after the last dose of study drug (Day 15) ]
  5. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to 30 days after last dose of study drug (Day 31) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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).
  2. 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).
  3. Healthy participants (Group 4).

Exclusion Criteria:

Participants who have:

  1. 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).
  2. Have severe hepatic encephalopathy ([greater than] > Grade II Portal Systemic Encephalopathy Score) (Group 1 to 3).
  3. Surgical porto-systemic shunts, including transjugular intrahepatic portosystemic shunt (Group 1 to 3).
  4. A history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to trial entry (Group 1 to 3).
  5. 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.
  6. Severe/advanced ascites and/or pleural effusion which requires emptying and albumin supplementation, as judged by the investigator (Group 1 to 3).
  7. 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).
  8. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277274


Locations
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Czechia
PRA CZ, s.r.o
Praha 7, Praha, Czechia, 170 00
Slovakia
Summit Center of Clinical Research
Bratislava, Slovakia, 83101
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] October 6, 2017
Statistical Analysis Plan  [PDF] September 5, 2018


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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03277274     History of Changes
Other Study ID Numbers: TAK-954-1006
2017-000714-37 ( EudraCT Number )
U1111-1196-9190 ( Registry Identifier: WHO )
First Posted: September 11, 2017    Key Record Dates
Results First Posted: September 25, 2019
Last Update Posted: September 25, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases