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Amino Acid

L-glutamine for Pharmacokinetics

Phase 4
Waitlist Available
Research Sponsored by Emmaus Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 day 1 (0.1 g/kg dose) and week 2 day 1 (0.3 g/kg dose. week 3 day 1 and week4 day1 (0.6 g/kg once daily dose)
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

L-glutamine has been approved in the US to reduce the acute complications of sickle cell disease (SCD) in adult and pediatric patients 5 years of age and older. The purpose of this single-center, open-label, phase 4 study is to evaluate the pharmacokinetic characteristics and safety of L-glutamine in patients with SCD.

Eligible Conditions
  • Pharmacokinetics
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 day 1 (0.1 g/kg dose) and week 2 day 1 (0.3 g/kg dose. week 3 day 1 and week4 day1 (0.6 g/kg once daily dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 day 1 (0.1 g/kg dose) and week 2 day 1 (0.3 g/kg dose. week 3 day 1 and week4 day1 (0.6 g/kg once daily dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under Curve (AUC) of L-glutamine at 0.1 g/kg twice daily, 0.3 g/kg twice daily, and 0.6 g/kg once daily in SCD patients
Half-life (t1/2) of L-glutamine at 0.1 g/kg twice daily, 0.3 g/kg twice daily, and 0.6 g/kg once daily in SCD patients
Maximum Plasma Concentration (Cmax) of L-glutamine at 0.1 g/kg twice daily, 0.3 g/kg twice daily, and 0.6 g/kg once daily in SCD patients
+1 more
Secondary study objectives
Ammonia levels
Effect of Food on L-glutamine Area Under Curve (AUC)
Effect of Food on L-glutamine Maximum Plasma Concentration (Cmax)
+5 more

Side effects data

From 2014 Phase 3 trial • 230 Patients • NCT01179217
81%
Sickle cell anaemia with crisis
25%
Constipation
23%
Nausea
22%
Pyrexia
21%
Headache
18%
Upper respiratory tract infection
17%
Cough
16%
Pain in extremity
15%
Vomiting
14%
Chest pain
13%
Back pain
13%
Arthralgia
12%
Abdominal pain
12%
Acute chest syndrome
11%
Abdominal pain upper
10%
Ocular icterus
9%
Pruritus
8%
Diarrhoea
8%
Acute Chest Syndrome
7%
Nasopharyngitis
7%
Urinary tract infection
7%
Nasal congestion
7%
Oropharnyngeal pain
6%
Fatigue
6%
Pneumonia
6%
Leukocytosis
5%
Anaemia
5%
Tachycardia
5%
Oedema peripheral
5%
Dizziness
5%
Dyspnoea
4%
Hypokalaemia
4%
Hypomanesaemia
3%
Asthma
3%
Bronchitis
3%
Gastroenteritis
3%
Hyperkalaemia
3%
Epistaxis
3%
Hypoxia
2%
Influenza
2%
Rash
1%
Leucocytosis
1%
Cardiac Arrest
1%
Gastritis
1%
Death
1%
Cholelithiasis
1%
Gastrointestinal viral infection
1%
Lobar pneumonia
1%
Osteomyelitis
1%
Pharnygitis streptococcal
1%
Sepsis
1%
Sinustitis
1%
Post-traumatic reaction
1%
Dehydration
1%
Joint effusion
1%
Transient ischaemic attack
1%
Haematuria
1%
Renal failure acute
1%
Bronchial hyperreactivity
1%
Pulmonary embolism
1%
Rhinitis allergic
1%
Skin ulcer
1%
Strabismus correction
1%
Aplastic anaemia
1%
Haemolysis
1%
Hypersplenism
1%
Pain
1%
Cholecystitis
1%
Cholecystitis acute
1%
Complication of device removal
1%
Device malfunction
1%
Fall
1%
Haemolytic transfusion reaction
1%
Pregnancy
1%
Deep vein thrombosis
1%
Thrombophlebits superficial
100%
80%
60%
40%
20%
0%
Study treatment Arm
L-glutamine
100% Maltodextrin

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: L-glutamineExperimental Treatment1 Intervention
Pharmacokinetic characteristics of L-glutamine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-Glutamine
FDA approved

Find a Location

Who is running the clinical trial?

Emmaus Medical, Inc.Lead Sponsor
7 Previous Clinical Trials
369 Total Patients Enrolled
Yutaka Niihara, MDStudy ChairEmmaus Medical, Inc.
2 Previous Clinical Trials
85 Total Patients Enrolled
~3 spots leftby Nov 2025
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