Clinical trials: Food Safety
Healthy Volunteers
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BVL-GSK098 in Healthy Volunteers
This is a phase I single-center, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics and food effect of BVL-GSK098 administered as single and multiple oral doses to…
- Trial name
- NCT04654143
- Where
- 2 sites in Spain
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- BioVersys AG
Healthy
Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction
A randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and the impact of food on pharmacokinetics of oral HS-10398 in Chinese healthy…
- Trial name
- NCT06383897
- Testing
- HS-10398
- Where
- China
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy Participants
A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants
The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese…
- Trial name
- NCT06144697
- Testing
- BMS-986465, Pegasys, Famotidine
- Where
- 2 sites in United States
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Looks at How Food Influences the Amount of BI 1358894 in the Blood
The primary objective of this trial is to investigate the safety and tolerability of BI 1358894 in healthy male subjects following oral administration of single rising doses.
- Trial name
- NCT03210272
- Testing
- BI 1358894, BI 1358894 (Test), BI 1358894 (Reference)
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Safety, Tolerability and Pharmacokinetics of KUC 7483 Tablets in Healthy Male Volunteers
Study to investigate safety, tolerability and pharmacokinetics of KUC 7483
- Trial name
- NCT02259907
- Testing
- KUC 7483 CL, High fat meal
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Nonalcoholic Steatohepatitis
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678, and the Effect of Food on ZSP0678 Pharmacokinetics
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single-and multiple-oral doses of ZSP0678 on fasted condition, and characterize PK of ZSP0678 on an empty stomach (fasted condition) and…
- Trial name
- NCT04137055
- Testing
- ZSP0678-10mg, ZSP0678-30mg, ZSP0678-60mg
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
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
Healthy
A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers
Study objectives To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine besylate after a single oral administration in healthy male volunteers.
- Trial name
- NCT01925313
- Testing
- CJ-30044, TALION TAB. 10mg
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Food Allergy
Long-term Extension Study of Ligelizumab in Food Allergy
This was an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who completed a ligelizumab Phase III study in food allergy.
- Trial name
- NCT05678959
- Testing
- Ligelizumab 120 mg, Ligelizumab 240 mg
- Where
- 49 sites in United States, Australia and 7 more
- Volunteers
- 163 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
A Phase 1 Study of XH-S003 in Healthy Volunteers
This is a phase 1, randomised, first-in-human, double-blinded, placebo-controlled, SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) study to assess the PK, safety, and tolerability of XH-S003 in healthy volunteers.
- Trial name
- NCT05946876
- Testing
- XH-S003 (A)
- Where
- Australia
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Pulmonary Disease, Chronic Obstructive
Study of Danirixin in Japanese Healthy Elderly Male Subjects
Danirixin is a selective chemokine receptor antagonist being developed as a potential anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT03136380
- Testing
- GSK1325756H
- Where
- 2 sites in Japan
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Overactive Bladder
A Two-Part Study to Determine: Best Medication Formulation and Food Effect
This is a two-part study. Part 1 is designed to find the best modified release formulation of GW423753; Part 2 is designed to use the selected formulation(s) from Part 1 to find out if food affects the way the medication is…
- Trial name
- NCT00427596
- Testing
- Solabegron
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABSK061 Mini-tablets in Healthy Adult Participants
To main objective is to evaluate the safety, tolerability, and pharmacokinetic profile of single or multiple oral doses of ABSK061 mini-tablets and to evaluate the effect of soft food with ABSK061 mini-tablets on its…
- Trial name
- NCT07007546
- Testing
- ABSK061
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Abbisko Therapeutics Co, Ltd
Eosinophilic Esophagitis (EoE)
SAD, MAD and Food Effect Evaluation of Safety, Tolerability, and PK of AQ280 in Healthy Subjects
The principal aim of this study is to obtain safety and tolerability data when AQ280 is administered orally as single and multiple doses to healthy subjects.
- Trial name
- NCT05485779
- Testing
- AQ280
- Where
- United Kingdom
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- AQILION AB
Cow's Milk Protein Allergy (CMPA)
TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)
This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed formula in young children aged 1~3 years with diagnosed with or highly suspected CMPA in a real-world clinical practice…
- Trial name
- NCT07855796
- Testing
- Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Teyi Yinuo Health Technology Co., Ltd.
Cancer
Examining the Feasibility and Impact of a Clinic-based Food Farmacy and Digital Culinary Medicine Program Among Cancer Survivors Treated in a Safety Net Hospital
The goal of this study is to develop and test the feasibility of a theory-driven digital culinary medicine program among food insecure cancer survivors referred from the University of Texas MD Anderson Cancer Center Oncology…
- Trial name
- NCT06760754
- Testing
- Digital culinary medicine intervention
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- M.D. Anderson Cancer Center
Healthy
A Phase 1 Single Dose and Multiple Ascending Dose Study to Assess the Relative Bioavailability, Food Effect, Safety, Tolerability and Pharmacokinetics of SYT-510 in Healthy Participants
Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510.
- Trial name
- NCT06670950
- Testing
- SYT-510
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Synendos Therapeutics AG
Healthy
Safety, Pharmacokinetics and Pharmacodynamics of BIRT 1696 BS in Healthy Human Subjects
The objectives are: 1. To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising single doses. 2. To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT 1696 BS after…
- Trial name
- NCT02254096
- Testing
- BIRT 1696 BS, Grapefruit juice (GFJ), High fat meal (HFM)
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809
To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate…
- Trial name
- NCT02068690
- Testing
- BI 425809 PfOS, BI 425809 tablet
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Milk Hypersensitivity
Tolerability and Safety of An Infant Formula
The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.
- Trial name
- NCT00938483
- Testing
- Nutramigen Lipil (Infant formula)
- Volunteers
- 108 people
- Sponsor
- Perrigo Nutritionals