Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects

Study Overview
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Brief Summary
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This study will assess the pharmacokinetics, safety and tolerability of a single dose of AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease with that in healthy matched control subjects.

Official Title
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An Open Label, Non-randomised, Parallel Group Study to Characterise and Compare the Pharmacokinetics, Safety and Tolerability of a Single Dose of AGO178C in Subjects With Mild, Moderate, Severe Renal Impairment and End-stage Renal Disease With That in Healthy Matched Control Subjects

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: AGO178C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild, moderate, severe renally impaired or ESRD patients. Healthy male or female subjects to match renally impaired patients in BMI (±15%), age (± 7 years) and gender (in this order). Smoking status (yes or no) will also be used as a final criterion, if deemed feasible by the Investigator. Exclusion Criteria: Pregnant or nursing (lactating) women Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study as defined in the protocol. Smokers, smoking 10 cigarettes or more per day from screening to study completion Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study Co-medication for healthy subjects Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGO178C<br> | Drug: AGO178C<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Composite of AGO178C pharmacokinetics in blood and urine samples. |  | pre dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h and 36 h post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Safety and tolerability of AGO178C as assessed by adverse events reports, vital signs, ECGs and safety laboratory tests. |  | Up to 9 Days post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AGO178C,, renal impairment,, ESRD,, pharmacokinetics