Clinical trials: Food Safety
Idiopathic Pulmonary Fibrosis
To Evaluate Food Effect on the PK and Safety After Oral DWN12088 Administration in Healthy Adult Volunteers
The pharmacokinetics (PK) and safety of single oral dose of DWN12088 in healthy adults will be compared and assessed on an empty stomach, after high-fat meal, or 2 hours after high-fat meal.
- Trial name
- NCT04767815
- Testing
- Diet A group, Diet B group, Diet C group
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Acute Coronary Syndrome
Study of LC23-1306 in Healthy Male Subjects
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic/pharmacodynamic characteristics.
- Trial name
- NCT01526577
- Testing
- LC23-1306, Ticagrelor
- Where
- South Korea
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Food Safety, Nutritive Value
Improving The Safety And Nutritional Adequacy Of The Home Food Supply Of Elderly Recipients Of Home Delivered Meals
Rutgers University will partner with the Meals on Wheels America (MOWA) and affiliated agencies in five states to conduct a study designed to improve food safety nutrition and emergency preparedness among homebound elderly…
- Conditions
- Food Safety, Nutritive Value, Homebound Persons, Frail Elderly
- Trial name
- NCT02719626
- Where
- 7 sites in United States
- Volunteers
- 740 people
- Sponsor
- Rutgers, The State University of New Jersey
Infections, Bacterial
Relative Bioavailability, Safety, Tolerability, Pharmacokinetics (PK) and Food Effect Study of GSK2140944 in Healthy Subjects
This study will be conducted in three parts (Part 1, Part 2 and Part 3). Part 1 of this study will evaluate the relative bioavailability of a single dose of GSK2140944 tablet formulation compared to the reference capsule…
- Trial name
- NCT02045849
- Testing
- GSK2140944 capsule, GSK2140944 tablet, Itraconazole capsule
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Overweight and Obesity
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of DA-302168S Tablets
To Evaluate the Safety, Tolerability and Pharmacokinetics on DA-302168S Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase I Clinical Trials in Healthy Subjects.
- Trial name
- DA168 (NCT06534320)
- Testing
- DA-302168S
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
Safety, Bioavailability
Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a…
- Conditions
- Safety, Bioavailability, Pharmacokinetics
- Trial name
- BA (NCT05627518)
- Testing
- Linaprazan glurate
- Where
- Slovenia
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Food Allergy, Anaphylaxis
PK/PD Study of IN-001 Sublingual Spray in Healthy Adults
This is an open-label, three-part study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as a single dose of L-dipivefrin (IN-001) sublingual spray or drop in healthy adults.
- Conditions
- Food Allergy, Anaphylaxis, Food Hypersensitivity, Food Allergy Peanut
- Trial name
- NCT07210320
- Testing
- Epinephrine Auto-Injector 0.3 mg/0.3 mL, Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle, IN-001 9.06 mg Sublingual Spray
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Insignis Therapeutics, Inc.
Chronic Spontaneous Urticaria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects.
- Trial name
- NCT07230418
- Testing
- HRS-3095 Tablet
- Where
- China
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
HIV Infections
VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI)
This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants.
- Trial name
- NCT06533280
- Testing
- Part A, C and D: VH3739937 500 mg, Part A: VH3739937 100 mg, Part B: Treatment A
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy Volunteers
A Study of the Safety, Tolerability, and Bioavailability of Orally Administered Venglustat in Healthy Adult Participants
The purpose of this study is to assess the effect of food on the bioavailability of venglustat and to assess the relative bioavailability of venglustat tablet swallowed whole with water versus a tablet chewed and then swallowed…
- Trial name
- NCT06418620
- Testing
- Venglustat
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects
A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using…
- Trial name
- NCT02852551
- Testing
- PAT-1251
- Where
- United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- PharmAkea, Inc.
Healthy
A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study of TLL018, With Food Effect, in Healthy Participants
TLL018 is developed for treatment of autoimmune and inflammatory diseases including rheumatoid arthritis. The purposes of this study are (1) determining if and at what doses TLL018 is safe and can be tolerated when administered…
- Trial name
- NCT04243083
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- TLL Pharmaceutical, LLC
Eosinophilic Esophagitis
EoE Food Desensitization
This is a single-center, prospective, pilot clinical trial in which children ages 3-17 years with eosinophilic esophagitis (EoE) who have a known food that triggers EoE flares receive oral desensitization with that specific food…
- Trial name
- NCT02881372
- Testing
- Oral food desensitization
- Where
- United States
- Sponsor
- The University of Texas Health Science Center, Houston
Healthy Volunteer
A Study of Safety, Pharmacokinetics (Including Food Effect) And Pharmacodynamics of RO5545965 in Healthy Volunteers
This randomized, Investigator/Subject-blind, adaptive single-ascending-dose, placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics (including the effect of food), and pharmacodynamics of…
- Trial name
- NCT01711801
- Testing
- RO5545965
- Where
- Netherlands
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Allergy;Food, Food Allergy Peanut
TRANS-FOODS: Preventing Peanut Allergy Through Improved Understanding of the Transcutaneous Sensitisation Route, Novel Food Processing and Skin Care Adaptations
This project aims to study the immune responses to peanut allergen in those with a skin barrier defect with and without skin massage, specifically it aims to: 1.
- Conditions
- Allergy;Food, Food Allergy Peanut, Pathways and Sources of Exposure
- Trial name
- TRANS-FOODS (NCT05407012)
- Testing
- Application of the barrier enhancing preparation.
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- King's College London
Diabetes
Safety, Acceptability and Efficacy of a Long-term Intervention With a Diabetes-specific Low-carbohydrate, High-mono-unsaturated Fatty Acid Containing Oral Nutritional Supplement on Glycaemic Control in Type 2 Diabetic Patients
The purpose of the study is to determine the safety, acceptability and the efficacy of a 12-week intervention with a diabetes-specific oral nutritional supplement on glycaemic control in type 2 diabetic patients with or at risk…
- Trial name
- NCT01241695
- Testing
- Oral nutritional supplement, food for special medical purposes
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Fresenius Kabi
NAFLD
Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
This is a randomized, single blind study to determine whether AXA1957, a novel composition of amino acids, is safe and well tolerated.
- Trial name
- NCT04073407
- Testing
- AXA1957
- Where
- 4 sites in United Kingdom
- Volunteers
- 9 people
- Sponsor
- Axcella Health, Inc
Healthy
Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of KBP-5074
This single ascending dose (SAD) study in healthy subjects will evaluate the safety, tolerability and pharmacokinetics of KBP-5074.
- Trial name
- NCT02228733
- Testing
- KBP-5074
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- KBP Biosciences
Peanut Allergy
Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children
Open-label, follow-up study for subjects who completed the EPITOPE study.
- Trial name
- EPOPEX (NCT03859700)
- Testing
- DBV712 250 mcg
- Where
- 26 sites in United States
- Volunteers
- 304 people
- Sponsor
- DBV Technologies
Peanut Allergies
Efficacy, Safety and Pharmacokinetics of LP-003 in Peanut Allergic Patients
This study will evaluate the safety and efficacy of LP-003 for an increasing the amount of peanut protein that people with a peanut allergy can tolerate without having allergic symptoms.
- Trial name
- NCT07785063
- Testing
- LP-003 Injection
- Volunteers
- 80 people
- Sponsor
- Longbio Pharma (Suzhou) Co., Ltd.