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

NCT00819468 | Completed Phase 1

• 1 other identifier: CL0600-017
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last)

  AUC0-last of Teduglutide will be evaluated.

  Pre-dose, 3 hours and 24 hours post-dose

• Maximum concentration (Cmax)

  Cmax of Teduglutide will be evaluated.

  Pre-dose, 3 hours and 24 hours post-dose

• Elimination Half-Life (t1/2)

  t1/2 of Teduglutide will be evaluated.

  Pre-dose, 3 hours and 24 hours post-dose

Secondary Outcomes (1)

• Number of participants with Adverse events (AEs)

  From start of study treatment to follow up (up to 9 days)

Study Arms (2)

Participants with Moderate Hepatic Impairment

EXPERIMENTAL

Participants with moderate hepatic impairment (Child-Pugh score of 7-9) will receive 20 mg of teduglutide.

Drug: Teduglutide

Healthy Volunteers

ACTIVE COMPARATOR

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.

Drug: Teduglutide

Interventions

Teduglutide DRUG

Participants will receive 20 mg dose of lypholized powder of teduglutide mixed with sterile water and injected subcutaneously into the abdomen.

Also known as: GATTEX

Healthy Volunteers; Participants with Moderate Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

University of Miami Clinical Pharmacology Unit

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

teduglutide; ALX-0600

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 9, 2009
• Study Start: July 26, 2007
• Primary Completion: August 23, 2007
• Study Completion: August 23, 2007
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

US (1)