Pharmacokinetics of 20 mg Teduglutide in Subjects With Moderately Impaired Hepatic Function Compared to Healthy Subjects With Normal Hepatic Function

This study has been completed.
Sponsor:
Information provided by:
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00819468
First received: January 8, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

This is a study to compare the pharmacokinetic profile of teduglutide in healthy subjects with normal hepatic function with subjects who have moderate hepatic impairment.


Condition Intervention Phase
Hepatic Impairment
Drug: teduglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacokinetics of 20 mg Teduglutide in Subjects With Moderately Impaired Hepatic Function Compared to Healthy Subjects With Normal Hepatic Function

Resource links provided by NLM:


Further study details as provided by NPS Pharmaceuticals:

Enrollment: 24
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subjects with moderate hepatic impairment (Child-Pugh score of 7-9)
Drug: teduglutide
20 mg dose of lypholized powder mixed with sterile water and injected subcutaneously into the abdomen.
Active Comparator: 2
Healthy volunteers with normal hepatic function matched to hepatic impaired subjects by age, gender, BMI, and renal function as measured by creatinine
Drug: teduglutide
20 mg dose of lypholized powder mixed with sterile water and injected subcutaneously into the abdomen.

Detailed Description:

24 subjects (equally divided between subjects 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. Subjects in both groups are matched up by sex, age, BMI, and renal function.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult male or female between 18 and 85 years of age
  • BMI of 18 to 40, inclusive
  • Creatinine clearance > 50 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 subjects 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 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 (

Inclusion for Subjects 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 subject's 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
  • Subjects with normal hepatic function will be matched collectively as a group by gender, age, and BMI with the subjects with moderately impaired hepatic function. Subjects with normal hepatic function will also be matched on an individually with the subjects with moderately impaired hepatic function with regard to renal function In addition to inclusion criteria # 1 to 8, subjects 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 subject 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
  • Subjects 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
  • Subjects 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819468

Locations
United States, Florida
University of Miami Clinical Pharmacology Unit
MIami, Florida, United States, 33136
Sponsors and Collaborators
NPS Pharmaceuticals
Investigators
Study Director: John Caminis, MD NPS Pharmaceuticals
  More Information

No publications provided

Responsible Party: John Wallens, NPS Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00819468     History of Changes
Other Study ID Numbers: CL0600-017, CL0600-017
Study First Received: January 8, 2009
Last Updated: January 8, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 19, 2014