Clinical trials: Food Safety
Healthy Volunteers
A Study Assessing the Safety of Oral ATH-399A in Healthy Adult Participants
This study will evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of ATH-399A in healthy adults and also evaluate the effect of food on ATH-399A in order to develop mechanism-based and/or…
- Trial name
- NCT06088784
- Testing
- ATH-399A, ATH-399A 10 mg, 5 mg ATH-399A capsule
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- HanAll BioPharma Co., Ltd.
Type 2 Diabetes Mellitus
To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers
This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
- Trial name
- NCT06492655
- Testing
- CKD-383(Fed), CKD-383(Fasted)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Community-acquired Infection
A Four Part Study to Investigate Relative Bioavailability, Safety and Tolerability of up to 5 Oral Formulation of GSK2251052 in Order to Identify a Formulation for Further Evaluation in a Future Later Phase Study
GSK2251052 is a member of a novel mechanistic and structural class of antibiotics that inhibits the bacterial enzyme leucyl tRNA synthetase (LeuRS) by forming a boron adduct with tRNA and is currently in development for the…
- Trial name
- Relative Bio (NCT01702350)
- Testing
- GSK2251052
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Inflammatory Disease
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects
Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy subjects
- Trial name
- NCT01695876
- Testing
- AMG 357
- Where
- 3 sites in New Zealand
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Subjects
A SAD, MAD, and FE Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of FM101 in Healthy Volunteers
This a double blind, randomized, placebo controlled, single and multiple ascending dose (SAD/MAD) study in healthy subjects. Safety evaluation will include adverse events (TEAEs), clinical laboratory values, vital signs, ECGs…
- Trial name
- NCT03879928
- Testing
- Single ascending doses of FM101, Multiple ascending doses of FM101, Food effects of FM101
- Where
- Netherlands
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Future Medicine
Psoriasis
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics and Food Effect of HS-20118
The study will be conducted in 2 parts (SAD and FE for Part 1 and MAD for Part2). Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of…
- Trial name
- NCT07033234
- Testing
- HS-20118
- Where
- China
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy
A Single and Multiple Ascending Dose Escalation and Food Effect Study of QX-4533 in Healthy Participants
The primary purpose of this study is to evaluate the safety and tolerability of QX-4533 following oral administration of single and multiple ascending doses in healthy participants.
- Trial name
- NCT07678463
- Testing
- QX-4533
- Where
- Australia
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- QuantX Biosciences, Inc.
Food Cravings
EXOMIND (BTL-699) for the Reduction of Food Cravings
The goal of this clinical trial is to evaluate if the treatment with BTL-699 device is able to temporarily reduce food cravings in adults above the age of 22 years.
- Trial name
- NCT06889298
- Testing
- Treatment with BTL-699
- Where
- Czechia
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- BTL Industries Ltd.
Smoking Cessation
A First-in-Human Study of SBP-9330 in Healthy Subjects
This is a single center, first-in-human, randomized, double-blind, placebo-controlled, Single-Ascending Dose (SAD) / Multiple-Ascending Dose (MAD) study incorporating a food-effect cohort.
- Trial name
- NCT04948827
- Testing
- SBP-9330
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Camino Pharma, LLC
Nonalcoholic Steatohepatitis (NASH)
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 on an empty stomach (fasted condition) and…
- Trial name
- NCT03392779
- Testing
- ZSP1601 25 mg, ZSP1601 50 mg, ZSP1601 100 mg
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Alzheimer Disease
Tricaprilin Liquid Formulation PK Study
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of new liquid formulations of tricaprilin, with the aim of finding a suitable formulation to advance in development.
- Trial name
- NCT05028114
- Testing
- AC-1202, AC-OLE-01, AC-OLE-02
- Where
- Australia
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Cerecin
Healthy
A Study to Investigate Safety, Tolerability and Pharmacokinetics of REM0045392 Compared With Placebo in Healthy Participants.
This study is testing if the medicine REM0045392 is safe and well-tolerated. It also looks at whether food affects how the medicine works.
- Trial name
- NCT07016464
- Testing
- REM0045392
- Where
- Belgium
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- reMYND
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
Single-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-281959 / ACT-246475 in Healthy Male Subjects
Study Part I is a single-ascending dose study. Healthy male subjects to be included in the study and randomized in 6 dose groups, Groups A-F (8 subjects per group).
- Trial name
- NCT01954615
- Testing
- 5 mg ACT-281959 prodrug formulation I (Group A), 20 mg ACT-281959 prodrug formulation I (Group B), ACT-281959 prodrug formulation I (Groups C to G doses to be defined)
- Where
- France
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Ischemic Stroke
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and Food Effects of DA414 Granules in Chinese healthy subjects with single and multiple doses.
- Trial name
- DA414 (NCT06525168)
- Testing
- DA414 Granules
- Where
- China
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Chendu DIAO Nine Hong Pharmaceutical Factory
Peanut Allergy
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active…
- Trial name
- PEOPLE (NCT03013517)
- Testing
- Viaskin Peanut 250µg
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 300 people
- Sponsor
- DBV Technologies
Hepatitis C
Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects
This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a study of the food effect in…
- Trial name
- INH-189-006 (NCT01445795)
- Testing
- 200 mg INX-08189 Fasted, 100 mg INX-08189 QD, 100 mg INX-08189 with low-fat meal
- Where
- 2 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- Bristol-Myers Squibb
Obstetric Labour, Premature, Premature Ejaculation
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.
- Trial name
- NCT00549211
- Testing
- GSK557296
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
First-in-human Study of MRT-6160 in Healthy Subjects
The principal aim of this study is to obtain safety and tolerability data when MRT-6160 is administered orally as single and multiple doses to healthy subjects.
- Trial name
- NCT06597799
- Testing
- MRT-6160
- Where
- 2 sites in United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Monte Rosa Therapeutics, Inc
Allergy, Peanut
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind…
- Trial name
- VITESSE (NCT05741476)
- Testing
- DBV712
- Where
- 87 sites in United States, Australia and 7 more
- Volunteers
- 600 people
- Sponsor
- DBV Technologies
Healthy
To Evaluate the Safety/Tolerability and Pharmacokinetic Characteristics in Healthy Volunteers
This clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 clinical trial to evaluate the safety/tolerability and pharmacokinetic characteristics, and to explore food effect and ethnic…
- Trial name
- NCT06703710
- Testing
- JW2286
- Where
- South Korea
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- JW Pharmaceutical