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Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants

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ClinicalTrials.gov Identifier: NCT00819468
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Tracking Information
First Submitted Date  ICMJE January 8, 2009
First Posted Date  ICMJE January 9, 2009
Last Update Posted Date May 14, 2021
Actual Study Start Date  ICMJE July 26, 2007
Actual Primary Completion Date August 23, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last) [ Time Frame: Pre-dose, 3 hours and 24 hours post-dose ]
    AUC0-last of Teduglutide will be evaluated.
  • Maximum concentration (Cmax) [ Time Frame: Pre-dose, 3 hours and 24 hours post-dose ]
    Cmax of Teduglutide will be evaluated.
  • Elimination Half-Life (t1/2) [ Time Frame: Pre-dose, 3 hours and 24 hours post-dose ]
    t1/2 of Teduglutide will be evaluated.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
Number of participants with Adverse events (AEs) [ Time Frame: From start of study treatment to follow up (up to 9 days) ]
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical/medicinal product which includes an exacerbation of a pre-existing illness, sign, symptom, or clinically significant laboratory test abnormality that is detected or diagnosed after study drug administration, pretreatment or post-treatment events that occur as a result of protocol-mandated procedures. An AE does not necessarily have to have a causal relationship with study drug.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants
Official Title  ICMJE Pharmacokinetics of 20 mg Teduglutide in Subjects With Moderately Impaired Hepatic Function Compared to Healthy Subjects With Normal Hepatic Function
Brief Summary This is a study to compare the pharmacokinetic profile of teduglutide in healthy participants with normal hepatic function with participants who have moderate hepatic impairment.
Detailed Description 24 participants (equally divided between participants with normal hepatic function and those with moderate hepatic impairment (defined by the protocol as a Child-Pugh classification of grade B score of 7-9)will be given a single injection of teduglutide (20mg) through subcutaneous injection into the abdomen. Blood samples would be taken within 30 minutes of dose through 24 hours post-dose. Participants in both groups are matched up by sex, age, BMI, and renal function.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hepatic Impairment
Intervention  ICMJE Drug: Teduglutide
Participants will receive 20 mg dose of lypholized powder of teduglutide mixed with sterile water and injected subcutaneously into the abdomen.
Other Name: GATTEX
Study Arms  ICMJE
  • Experimental: Participants with Moderate Hepatic Impairment
    Participants with moderate hepatic impairment (Child-Pugh score of 7-9) will receive 20 mg of teduglutide.
    Intervention: Drug: Teduglutide
  • Active Comparator: Healthy Volunteers
    Healthy volunteers with normal hepatic function matched to hepatic impaired participants by age, gender, BMI, and renal function as measured by creatinine will receive 20 mg of teduglutide.
    Intervention: Drug: Teduglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2009)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 23, 2007
Actual Primary Completion Date August 23, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult male or female between 18 and 85 years of age
  • BMI of 18 to 40, inclusive
  • Creatinine clearance (greater) > 50 milliliter per minute(mL/min)
  • Able to understand and willing to sign an informed consent form (ICF)
  • Willing and able to be confined at the study site for approximately 2.5 days
  • Female participants who are postmenopausal, surgically sterilized, or women of childbearing potential (WOCBP) using an effective form of birth control during the study
  • WOCBP must have a negative urine beta human chorionic gonadotropin (β-hCG) result at screening (Days -28 to -2) and check-in (Day -1)
  • Negative urine test for selected drugs of abuse and alcohol at screening and check-in (Day-1)

Inclusion for participants with Impaired Hepatic Function (in addition to above criteria):

  • Documented moderately impaired hepatic function defined by a total score of 7 to 9 on the Child-Pugh Classification at screening and check-in
  • No clinically significant change in disease status within the 3 months prior to study entry
  • Abnormal laboratory results that are related to the participants underlying condition clinically stable as deemed by the investigator
  • Abstained from alcohol use within 90 days prior to study entry when hepatic impairment is known to be secondary to alcohol abuse
  • On medication and/or treatment regimen if, in the opinion of the investigator, the underlying disease is under control
  • Participants with normal hepatic function will be matched collectively as a group by gender, age, and BMI with the participants with moderately impaired hepatic function. Participants with normal hepatic function will also be matched on an individually with the participants with moderately impaired hepatic function with regard to renal function In addition to inclusion criteria # 1 to 8, participants with normal hepatic function must also meet the following inclusion criteria to be eligible for participation in this study:
  • Similar level of renal function based on Cockroft-Gault equation as the matched participant with moderately impaired hepatic function
  • Medically healthy with normal or clinically insignificant clinical results at screening and check-in

Exclusion Criteria:

  • Donated 1 pint or more of blood or blood products within 7 days prior to the study, and/or had a blood or plasma donation within 7 days prior to the study
  • Participated in any other investigational drug trial within 30 days prior to study entry
  • Have a hemoglobin level < 10.0 g/dL at screening (Days -28 to -2)
  • Have any condition that, in the opinion of the investigator or sponsor, would make them unsuitable for the study
  • Participants with Impaired Hepatic Function (in addition to exclusion criteria 1-4):
  • Acceptable Child-Pugh score (Grade B, score of 7 to 9), which is associated with conditions such as metastatic cancer rather than impaired hepatic function
  • Participants with Normal Hepatic Function (in addition to exclusion criteria 1-4
  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
  • History or evidence of congenital nonhemolytic hyperbilirubinemia
  • History or evidence of gallstone disease or stomach or intestinal surgery, with the exception of appendectomy
  • History or evidence of colorectal cancer
  • History or evidence of malabsorption, pancreatic disease or gastrointestinal disorders, such as irritable bowel syndrome, Crohn's disease or ulcerative colitis
  • Taking prescription or over-the-counter medication (with the exception of daily low dose aspirin regimen and/or birth control)during the 7 days preceding confinement to the clinical research unit, and/or who anticipate a need to use prescription or over-the-counter medication during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00819468
Other Study ID Numbers  ICMJE CL0600-017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeda ( Shire )
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Takeda
PRS Account Takeda
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP