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A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.
This is an open-label, single-dose, parallel group study to evaluate the PK, safety, tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4 groups based on renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: End Stage Renal Disease (ESRD) | Experimental | Subjects with CrCl <20ml/min will receive MEDI0382 administered subcutaneously |
|
| Group 2: Severe and ESRD Subjects | Experimental | Subjects with CrCl >20 and < 30 ml/min will receive MEDI0382 administered subcutaneously |
|
| Group 3: Healthy Subjects | Active Comparator | Subjects with CrCl >90 ml/min will receive MEDI0382 administered subcutaneously |
|
| Group 4: Moderate Renal Disease | Experimental | Subjects with CrCl > or equal to 30 and < 60 mL/min will receive MEDI0382 administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI0382 | Drug | MEDI0382 administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration of MEDI0382 (Cmax) | The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data | 0-48 hours |
| Area under the Concentration Time Curve (AUC) of MEDI0382 | The area under the plasma concentration-time curve to 48 hours concentration determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations | 0-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed concentration (Tmax) | Time to maximum observed concentration. | 0-48 hours |
| apparent clearance (Cl/F) | The apparent clearance will be calculated as CL/F=Dose/AUC(0-inf) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Kiel | 24105 | Germany | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37140727 | Derived | Klein G, Petrone M, Yang Y, Hoang T, Hazlett S, Hansen L, Flor A. Pharmacokinetics and Safety of Cotadutide, a GLP-1 and Glucagon Receptor Dual Agonist, in Individuals with Renal Impairment: A Single-Dose, Phase I, Bridging Study. Clin Pharmacokinet. 2023 Jun;62(6):881-890. doi: 10.1007/s40262-023-01239-1. Epub 2023 May 4. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000624433 | cotadutide |
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| 0-48 hours |
| AUCinf | The AUC extrapolated to infinity will be calculated, where data permit, as the sum of AUC((0-t) and Ct/z, where Ct is the observed plasma concentration obtained from the log-linear regression analysis of the last quantifiable time-point and z is the terminal phase rate constant. | 0-48 hours |
| Half-life (T1/2) | The apparent terminal elimination half-life (t1/2) obtained as the ratio of ln2/z, where z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data | 0-48 hours |
| Anti-drug Antibody (ADA) titer | ADA titer through to day 28 | Day -1 to day 28 |
| Number of subjects with Adverse Events | Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs) | Study onset till 28 days post dosing |
| Number of subjects with Adverse Events | Vital Signs (systolic and diastolic blood pressure, pulse rate, temperature and respiratory rates) | Study onset till 28 days post dosing |
| Number of subjects with Adverse Events | Clinical laboratory assessments (serum chemistry, hematology, and urinalysis) | Study onset till 28 days post dosing |
| München |
| 81241 |
| Germany |
| Research Site | Auckland | 1010 | New Zealand |
| Research Site | Christchurch | 8011 | New Zealand |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |