Hepatic ImpairmentPhase 1NCT00819468
Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants
A Phase 1 study testing Teduglutide in people with Hepatic Impairment, run by Shire at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Teduglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2007to 23 Aug 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Clinical Pharmacology Unit
Miami, Florida, 33136
About this study
Official title: Pharmacokinetics of 20 mg Teduglutide in Subjects With Moderately Impaired Hepatic Function Compared to Healthy Subjects With Normal Hepatic Function
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.
Read the 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.
- Conditions
- Hepatic Impairment
- Being tested
- Teduglutide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeduglutideDrug
Also called GATTEX
Participants will receive 20 mg dose of lypholized powder of teduglutide mixed with sterile water and injected subcutaneously into the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment (Child-Pugh score of 7-9) will receive 20 mg of teduglutide. Receives: 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. Receives: Drug: Teduglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-dose, 3 hours and 24 hours post-dose
Maximum concentration (Cmax)
Cmax of Teduglutide will be evaluated.
Measured: Pre-dose, 3 hours and 24 hours post-dose
Elimination Half-Life (t1/2)
t1/2 of Teduglutide will be evaluated.
Measured: Pre-dose, 3 hours and 24 hours post-dose
Secondary outcomes (1)
Number of participants with Adverse events (AEs)
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.
Measured: From start of study treatment to follow up (up to 9 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study start26 Jul 2007
- Primary completion23 Aug 2007
- Study completion23 Aug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819468
- Sponsor's protocol ID
- CL0600-017
- Status last verified
- May 2021
- First submitted
- 8 Jan 2009
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of 20 mg Teduglutide in Subjects With Moderately Impaired Hepatic Function Compared to Healthy Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT00819468
- Acronym / sponsor ID
- CL0600-017
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2007 (actual)
- Primary completion
- 23 Aug 2007 (actual)
- Study completion
- 23 Aug 2007 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Moderate Hepatic Impairment | Experimental | Drug: TeduglutideParticipants with moderate hepatic impairment (Child-Pugh score of 7-9) will receive 20 mg of teduglutide. |
| Healthy Volunteers | Active comparator | Drug: TeduglutideHealthy 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (13 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeduglutideAlso: GATTEXParticipants will receive 20 mg dose of lypholized powder of teduglutide mixed with sterile water and injected subcutaneously into the abdomen. | Drug | Healthy Volunteers, Participants with Moderate Hepatic Impairment |
Primary outcome
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.
1 secondary outcome
Number of participants with Adverse events (AEs)
Time frame: From start of study treatment to follow up (up to 9 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Teduglutide in people with Hepatic Impairment, run by Shire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.