Clinical trials: Food Safety
Healthy
A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood
This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further…
- Trial name
- NCT06255340
- Testing
- BI 3031185
- Where
- Germany
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-383 and ACHN-789
This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug interaction potential of ACHN-383 and ACHN-789…
- Trial name
- NCT03163550
- Testing
- ACHN-383, ACHN-789
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Achaogen, Inc.
Healthy Subjects
A First-in-human Phase 1 Study of CP1050
This is a Phase I, first-in-human, double-blind, single-centre, randomised, placebo-controlled, single and multiple oral dose study in healthy subjects conducted in 4 parts (Part 1; Single-ascending dose, Part 2; Food-effect…
- Trial name
- NCT03468413
- Where
- United Kingdom
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Curadim Pharma Co., Ltd.
Esophageal Food Bolus Obstruction
Esophageal Food Impaction
This study is designed to obtain data on the safety and efficacy of oral nitroglycerin solution for the treatment of esophageal food impaction in patients presenting to the Emergency Department with presumed esophageal food…
- Trial name
- ONEFIT (NCT03305848)
- Testing
- Nitrostat 0.4Mg Sublingual Tablet
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- HealthPartners Institute
Growth Failure
Safety Study of Infant Formula With Partially Hydrolized Whey
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color.
- Trial name
- NCT00548106
- Testing
- partially hydrolyzed whey, Nan HA
- Where
- Israel
- Sponsor
- Soroka University Medical Center
Non-Alcoholic Fatty Liver Disease
A Randomized, Double-blind, Single-center Phase I/IIa Study of XTYW007 Tablets in Subjects.
Aimed at evaluating the safety, tolerability, and pharmacokinetic characteristics of single and multiple doses of XTYW007 in healthy subjects and healthy subjects with elevated LDL-C, as well as studying the effects of food on…
- Trial name
- NCT07407634
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Xi'an Xintong Pharmaceutical Research Co.,Ltd.
Healthy
Food Effect Study For New Formulation
The main objective of this study is to estimate the effect of food on sildenafil pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of sildenafil citrate.
- Trial name
- NCT01656798
- Testing
- sildenafil citrate
- Where
- Singapore
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Urothelial Carcinoma, Carcinoma, Non-Small Cell Lung
A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)
This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the…
- Conditions
- Urothelial Carcinoma, Carcinoma, Non-Small Cell Lung, Small Cell Lung Carcinoma, Triple Negative Breast Carcinoma
- Trial name
- NCT03232593
- Testing
- Atezolizumab
- Where
- 56 sites in South Korea
- Volunteers
- 1,758 people
- Sponsor
- Hoffmann-La Roche
Peanut Allergy
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).
- Trial name
- EPITOPE (NCT03211247)
- Testing
- Part A Viaskin Peanut 250 mcg, Part A Viaskin Peanut 100 mcg, Part B Viaskin Peanut 250 mcg
- Where
- 51 sites in United States, Australia and 6 more
- Volunteers
- 414 people
- Sponsor
- DBV Technologies
Cow Milk Allergy, Food Allergy
Effectiveness and Safety of Milk Ladders in Children with IgE-Mediated Cow's Milk Protein Allergy
Cow's milk protein allergy (CMPA) is one of the most common food allergies in early childhood. The first-line treatment of CMPA is the elimination of cow's milk proteins (CMPs) from the child's or maternal diet.
- Trial name
- NCT06664918
- Testing
- oral food challenge (OFC)
- Where
- 2 sites in Poland
- Volunteers
- 92 people
- Sponsor
- Medical University of Warsaw
Malaria, Falciparum
A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.
- Trial name
- NCT06171113
- Testing
- GSK4024484C
- Where
- United Kingdom
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Psoriasis, Healthy
A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)
The purpose of this trial is to learn about a trial medicine called MK-8644. This trial is the first time researchers will give MK-8644 to people.
- Trial name
- NCT07850310
- Testing
- MK-8644
- Where
- Australia
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy, COVID-19
Study to Evaluate Safety, Tolerability, PK and the Food Effect on PK of ASC11/RTV Tablets in Healthy Subjects
This is a randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, and pharmacokinetics of ASC11 plus ritonavir tablets in healthy subjects and an open-label, cross-over study…
- Trial name
- NCT05718518
- Testing
- ASC11 tablets, RTV tablets
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
Healthy
Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers
Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of food effect by re-dosing at 50 mg and 150 mg
- Trial name
- NCT02259842
- Testing
- BI 34021 FU2 solution, BI 34021 FU2 tablet, High fat, high calorie breakfast
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Tolerability
Study to Investigate Single Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects
1. The main purpose of this study is to assess the safety and tolerability of AZD5213 after single oral doses. 2. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and…
- Trial name
- NCT01121302
- Testing
- AZD5213
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pre-surgical Anxiety, Blood Glucose Concentration
Vis Pre Surgery Medical Food Validation Study
A pre-market, confirmatory, prospective, interventional, clinical investigation to confirm the clinical safety and performance profile of Vis Pre-surgeryTM that the medical food will reduce pre and post-surgical complications…
- Conditions
- Pre-surgical Anxiety, Blood Glucose Concentration, Blood Cortisol Levels, Electrolyte Levels
- Trial name
- NCT07359222
- Testing
- Pre-surgical medical food
- Where
- India
- Volunteers
- 67 people
- Sponsor
- TM Nutrition LLC
Healthy
Safety and Tolerability of Lu AG06479 in Healthy Young Men
The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.
- Trial name
- NCT04473651
- Testing
- Lu AG06479
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Allergy, Peanut Allergy
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
- Trial name
- NCT07003919
- Testing
- DBV712 250 mcg
- Where
- 91 sites in United States, Australia and 6 more
- Volunteers
- 480 people
- Sponsor
- DBV Technologies
Healthy
Single and Multiple Ascending Oral Dose Study of RX-10001 in Healthy Volunteers
This study is being conducted to determine the safety, tolerability, pharmacodynamics and pharmacokinetics of RX-10001.
- Trial name
- NCT00941018
- Testing
- RX-10001
- Where
- Netherlands
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Resolvyx Pharmaceuticals, Inc
Obesity, Elevated High-sensitivity C-reactive Protein (hsCRP)
A Study to See How Safe a New Medicine (NNC6022-0004) is in Healthy People and People Living With Obesity
This study is being done to look at the efficacy single and multiple ascending dose study investigating safety, tolerability, pharmacokinetics, food effect and target engagement in healthy adults including a single cohort in…
- Trial name
- NCT07693868
- Testing
- NNC6022-0004
- Where
- Netherlands
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S