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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment (Child-Pugh score of 7-9) will receive 20 mg of 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teduglutide | Drug | Participants will receive 20 mg dose of lypholized powder of teduglutide mixed with sterile water and injected subcutaneously into the abdomen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Inclusion for participants with Impaired Hepatic Function (in addition to above criteria):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Clinical Pharmacology Unit | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| C494910 | teduglutide |
| C438272 | ALX-0600 |
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| From start of study treatment to follow up (up to 9 days) |