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Last Updated: December 23, 2024

CLINICAL TRIALS PROFILE FOR AMMONIUM CHLORIDE IN PLASTIC CONTAINER


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All Clinical Trials for AMMONIUM CHLORIDE IN PLASTIC CONTAINER

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01440478 ↗ The Effects of Urinary pH Changes on an Investigational Compound in Healthy Subjects Completed Eli Lilly and Company Phase 1 2011-09-01 This study is designed to explore the effect of increased and decreased urinary pH on the single pharmacokinetic (PK) dose of LY2140023 and its active metabolite LY404039. All participants will receive the three treatments in a randomized order.
NCT01690039 ↗ Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis Completed University Hospital Inselspital, Berne 2012-09-01 Purpose 1. To compare the performance of the two currently employed urinary acidifications tests in stone formers, the furosemide/fludrocortisone and ammonium chloride loading test. 2. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on urinary acidification in stone formers.
NCT02360826 ↗ Statin Distribution Completed American Heart Association Phase 1 2014-06-17 Anticipating an increased use of statins in children and adolescents, it is imperative that we understand the genetic and developmental characteristics affecting the pharmacokinetics and pharmacodynamics of statins in childhood and adolescence. Simply extrapolating pediatric dosing guidelines from adult dose-exposure-response relationships fails to recognize the potential impact of growth and development in pediatric patients, which may have important clinical implications for drug efficacy or toxicity. Current evidence indicates that genetic variation in the SLCO1B1 transporter is important for statin disposition and toxicity in adults. The ontogeny of SLCO1B1 during human growth and development has not been well characterized, and limited pediatric data indicate that the genotype-phenotype relationship in children is the opposite of that observed in adults. Therefore, investigating the relative roles of SLCO1B1 ontogeny and genetic variation in statin disposition and response is key to determining the age at which the statin dose-exposure-response relationship mimics adults, and has important implications for other medications transported by the SLCO1B1 protein. As the first step in this process, our specific aims for the current investigation are 1) to determine the effect of genetic variation of SLCO1B1 on the pharmacokinetics of pravastatin and simvastatin by comparing Cmax, AUC and elimination between children and adolescents with 2 functional SLCO1B1 alleles and those with one or more variant alleles, and 2) to determine if the magnitude of the genetic effect on pravastatin pharmacokinetics (defined as Cmax, AUC and elimination) is equivalent to the effect on simvastatin pharmacokinetics. As a secondary aim, Cmax and AUC of pravastatin and simvastatin will be compared between children and adolescents for each genotype group. These results will be utilized to determine the sample size necessary to adequately power future studies characterizing the role of ontogeny on statin disposition. The ultimate goal of this proposed investigation is to establish the role of genetic variation in key transporters on the dose-exposure relationship of two commonly used statin drugs in children. This study is the first step in a series of investigations aimed at determining the mechanisms behind variations in physiologic response, clinical efficacy and significant adverse effect risk that surround the statin drugs in children and adolescents.
NCT02360826 ↗ Statin Distribution Completed Children's Mercy Hospital Kansas City Phase 1 2014-06-17 Anticipating an increased use of statins in children and adolescents, it is imperative that we understand the genetic and developmental characteristics affecting the pharmacokinetics and pharmacodynamics of statins in childhood and adolescence. Simply extrapolating pediatric dosing guidelines from adult dose-exposure-response relationships fails to recognize the potential impact of growth and development in pediatric patients, which may have important clinical implications for drug efficacy or toxicity. Current evidence indicates that genetic variation in the SLCO1B1 transporter is important for statin disposition and toxicity in adults. The ontogeny of SLCO1B1 during human growth and development has not been well characterized, and limited pediatric data indicate that the genotype-phenotype relationship in children is the opposite of that observed in adults. Therefore, investigating the relative roles of SLCO1B1 ontogeny and genetic variation in statin disposition and response is key to determining the age at which the statin dose-exposure-response relationship mimics adults, and has important implications for other medications transported by the SLCO1B1 protein. As the first step in this process, our specific aims for the current investigation are 1) to determine the effect of genetic variation of SLCO1B1 on the pharmacokinetics of pravastatin and simvastatin by comparing Cmax, AUC and elimination between children and adolescents with 2 functional SLCO1B1 alleles and those with one or more variant alleles, and 2) to determine if the magnitude of the genetic effect on pravastatin pharmacokinetics (defined as Cmax, AUC and elimination) is equivalent to the effect on simvastatin pharmacokinetics. As a secondary aim, Cmax and AUC of pravastatin and simvastatin will be compared between children and adolescents for each genotype group. These results will be utilized to determine the sample size necessary to adequately power future studies characterizing the role of ontogeny on statin disposition. The ultimate goal of this proposed investigation is to establish the role of genetic variation in key transporters on the dose-exposure relationship of two commonly used statin drugs in children. This study is the first step in a series of investigations aimed at determining the mechanisms behind variations in physiologic response, clinical efficacy and significant adverse effect risk that surround the statin drugs in children and adolescents.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for AMMONIUM CHLORIDE IN PLASTIC CONTAINER

Condition Name

Condition Name for AMMONIUM CHLORIDE IN PLASTIC CONTAINER
Intervention Trials
Acidosis, Renal Tubular 1
Drug Distribution 1
Healthy 1
Healthy Subjects 1
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Condition MeSH

Condition MeSH for AMMONIUM CHLORIDE IN PLASTIC CONTAINER
Intervention Trials
Nephrolithiasis 1
Kidney Calculi 1
Acidosis, Renal Tubular 1
Acidosis 1
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Clinical Trial Locations for AMMONIUM CHLORIDE IN PLASTIC CONTAINER

Trials by Country

Trials by Country for AMMONIUM CHLORIDE IN PLASTIC CONTAINER
Location Trials
Switzerland 1
United Kingdom 1
United States 1
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Trials by US State

Trials by US State for AMMONIUM CHLORIDE IN PLASTIC CONTAINER
Location Trials
Missouri 1
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Clinical Trial Progress for AMMONIUM CHLORIDE IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for AMMONIUM CHLORIDE IN PLASTIC CONTAINER
Clinical Trial Phase Trials
Phase 1 2
N/A 1
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Clinical Trial Status

Clinical Trial Status for AMMONIUM CHLORIDE IN PLASTIC CONTAINER
Clinical Trial Phase Trials
Completed 4
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Clinical Trial Sponsors for AMMONIUM CHLORIDE IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for AMMONIUM CHLORIDE IN PLASTIC CONTAINER
Sponsor Trials
Eli Lilly and Company 1
University Hospital Inselspital, Berne 1
American Heart Association 1
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Sponsor Type

Sponsor Type for AMMONIUM CHLORIDE IN PLASTIC CONTAINER
Sponsor Trials
Other 4
Industry 1
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