Clinical trials: Amino Acids
Urea Cycle Disorder
A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders
This is an open-label study consisting of a transition period to RAVICTI, followed by a safety extension period for at least 6 months and up to 24 months of treatment with RAVICTI, depending on age at enrollment.
- Trial name
- NCT02246218
- Testing
- RAVICTI
- Where
- 17 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Amgen
End Stage Renal Disease on Dialysis (Diagnosis)
Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis
The aim of the study is to compare intradialytic plasma kinetics of amino acids after administration per os of Renoral or intravenous administration of amino acids in patients with end-stage renal disease treated with…
- Trial name
- NCT03807583
- Testing
- Aminoven 10%, RENORAL
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Indigo Therapeutics
Coronary Artery Disease
Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.
- Trial name
- REPAIR (NCT03269461)
- Testing
- Angiography and Optical Coherence Tomography evaluations
- Where
- 5 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Scitech Produtos Medicos SA
Preterm Infants
Effect of Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Infants
The objectives of the study were to assess the serum selenium, zinc, and copper status and plasma and white blood cell antioxidant enzyme activities of low birth weight infants receiving selenium supplemented and non-selenium…
- Trial name
- NCT02066610
- Testing
- selenium and sodium selenate supplementation, selenium and sodium selenite supplementation, Without selenium and sodium selenate supplementation
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Abbott Nutrition
Postprandial Amino Acid Concentrations in Healthy Adults
Amino Acid Concentrations in Serum After Intake of Different Protein Sources
This study assesses the amino acid concentrations in subject serum after intake of different types of proteins. The study is divided in two consecutive sub-studies.
- Trial name
- NCT06153225
- Testing
- Protein products
- Where
- Netherlands
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Hepatic Encephalopathy, Urea Cycle Disorders
A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group
The purpose of this study is to determine the safety and tolerability of GT4P administered orally as a single dose, and twice daily for 7 consecutive days, to subjects with hepatic impairment with cirrhosis (Child-Pugh scores of…
- Trial name
- NCT00986895
- Testing
- HPN-100
- Where
- 2 sites in Ukraine
- Volunteers
- 32 people
- Sponsor
- Amgen
Infertility
Amino Acid Profiling of Spent Culture Medium
The purpose of this study is to develop an algorithm for embryo selection based on amino acid profiling (AAP) of spent culture medium.
- Trial name
- EmbryoSure (NCT01587547)
- Where
- 2 sites in United Kingdom
- Volunteers
- 10 people
- Sponsor
- Origio A/S
Homocystinuria
Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers
This is a Phase 1, double-blind (Sponsor-open), placebo-controlled, randomized, dose-escalation, inpatient study using a multiple-ascending dose (MAD) design to assess the safety, tolerability, and PD of SYNB1353 in HVs.
- Trial name
- HCU (NCT05462132)
- Testing
- SYNB1353
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Synlogic
Muscle Strength, Athletic Performance
HME Amino Acid Supplementation for Strength, Performance, and Recovery in Trained Adult Males
This pilot randomized controlled trial evaluates HME (Human Muscle Equivalent), a free-form amino acid supplement formulated to match the amino acid composition of human skeletal muscle, taken at its Health Canada licensed dose…
- Conditions
- Muscle Strength, Athletic Performance, Resistance Training
- Trial name
- NCT07715201
- Testing
- HME (Human Muscle Equivalent)
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Orivian inc
Growth
Growth of Infants Fed an Amino Acid Infant Formula
The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period…
- Trial name
- NCT01583673
- Testing
- Amino Acid Formula
- Where
- 17 sites in United States
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Urea Cycle Disorders
Study of the Safety of HPN (Hyperion)-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD)
This was a long-term safety study HPN-100 in urea cycle disorder (UCD) subjects. Subjects were assessed regularly for safety and control of their venous ammonia.
- Trial name
- NCT00947297
- Testing
- HPN-100
- Where
- 22 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Amgen
Tyrosinemias, Alkaptonuria
Evaluation of TYR Sphere
For 28 days, 20 patients with tyrosinaemia will take TYR sphere as part of the usual dietary management of their condition. Patients will record their adherence to recommended intakes each day, gastrointestinal symptoms (if any)…
- Conditions
- Tyrosinemias, Alkaptonuria, Tyrosinemia, Type I, Tyrosinemia, Type II
- Trial name
- NCT04196959
- Testing
- TYR sphere
- Where
- 2 sites in United Kingdom
- Volunteers
- 18 people
- Sponsor
- Vitaflo International, Ltd
Phenylketonuria
A Trial to Examine if Repinatrabit is Processed Differently in Adults With Reduced Liver or Kidney Function Compared to Adults With Normal Liver and Kidney Function
This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have…
- Trial name
- NCT07713758
- Testing
- Repinatrabit
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy Volunteers
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
The purpose of this study is to assess the drug-drug interaction (DDI) of repinatrabit with ethinyl estradiol/norethindrone or norethisterone (EE/NE), metformin, rosuvastatin, carbamazepine, and methotrexate in healthy…
- Trial name
- NCT07446400
- Testing
- Repinatrabit, EE/NE, Metformin
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Phenylketonuria
First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuria
The goal of Parts A and B of this Phase 1/2, first-in-human, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of single (SAD) and multiple (MAD) ascending doses of oral JNT-517 in healthy…
- Trial name
- NCT05781399
- Testing
- JNT-517 Suspension, JNT-517 Tablet
- Where
- 15 sites in United States, Australia
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Children Requiring Amino Acid-based Formula Tube Feeding, Enteral Feeding Intolerance
Retrospective Review of Amino Acid Formula Use at a Children's Center
This is a retrospective review of data documented in medical records.
- Trial name
- NCT03497091
- Testing
- Enteral Formula
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Société des Produits Nestlé (SPN)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency
Ornithine Transcarbamylase (OTC) deficiency, the most common urea cycle disorder, is an inherited metabolic disorder caused by a genetic defect in a liver enzyme responsible for detoxifying of ammonia.
- Conditions
- Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease, Ornithine Carbamoyltransferase Deficiency (Disorder), Urea Cycle Disorders, Inborn
- Trial name
- NCT06255782
- Testing
- ECUR-506
- Where
- 12 sites in United States, Australia and 2 more
- Volunteers
- 20 people
- Sponsor
- iECURE, Inc.
Biotinidase Deficiency
Study of ORL-1B in Patients With Biotinidase Deficiency
An Open-label, Single-arm, Phase 2 Study of Biotin in Patients With Biotinidase Deficiency.
- Trial name
- NCT03269045
- Testing
- ORL-1B
- Volunteers
- 20 people
- Sponsor
- Orpha Labs
Dry Eye Syndrome (DES)
Evaluation of Performance and Safety of Eye Drops With Hyaluronic Acid 0.30% and 0.15%
This is a profit, multicentric, prospective, open-label, non-pharmacological clinical investigation aim to evaluate the efficacy and tollerability of two types of eye drops containing Hyaluronic acid (HA) with different…
- Trial name
- NCT06189456
- Testing
- BLUgel A, BLUyal A
- Where
- 3 sites in Italy
- Volunteers
- 101 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Cancer Patients With Cachexia
Evaluation of the Effects of a Mixture of Amino Acids (Amixea) on Lean Body Mass and Muscle Strengh of Patients With Unresectable Advanced Non-small Cell Lung Cancer
The primary objectives of this study are to evaluate the effects of an amino acid mixture (Amixea) on the body composition as assessed by DXA, and on QMVC as assessed by strain gauge, in advanced NSCLC patients, compared to…
- Trial name
- NCT02877966
- Testing
- Amixea
- Where
- 3 sites in Australia
- Volunteers
- healthy volunteers welcome
- Sponsor
- Helsinn Healthcare SA