Clinical trials: Food Safety
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
Healthy Subjects
Clinical Trial In Healthy Volunteers And Health Elderly Volunteers To Evaluate The Safety, Tolerability And Blood Concentration After Single And Multiple Escalating Oral Doses Of PF-06751979.
This study will test the safety, tolerability and blood concentrations of single and multiple oral doses of PF-06751979 in health subjects and healthy elderly subjects.
- Trial name
- NCT02793232
- Testing
- PF-06751979 single dose, PF-06751979 multiple ascending dose, PF-06751979 multiple dose
- Where
- Belgium
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants
The main purpose of this study in healthy participants is to learn more about the safety of LY3509754 and any side effects that might be associated with it.
- Trial name
- NCT04586920
- Testing
- LY3509754, Itraconazole, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect
To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW 1. In rising single doses 2. With and without a 64 g fat breakfast at one selected dose
- Trial name
- NCT02268760
- Testing
- BILN 2061 ZW single rising doses, BILN 2061 ZW fixed dose, Standardized breakfast
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Herpes Genitalis, Herpes Zoster
Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food
The objective of this study is to evaluate the safety and tolerability of single rising doses of ASP2151 under fasted condition in healthy male subjects.
- Trial name
- NCT02852876
- Testing
- ASP2151
- Where
- France
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe Ltd.
Stable Coronary Artery Disease, Healthy Volunteers
A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease
This study will evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) (Part 1a), multiple ascending doses (MAD) (Part 1b), and the food effect (Part 1c) of RO7763505 in…
- Trial name
- NCT07495813
- Testing
- RO7763505
- Where
- Netherlands
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Volunteers
A Healthy Subject Study With Z-360 and Placebo
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (including food effect) of single and multiple doses of Z-360 in healthy Japanese subjects.
- Trial name
- NCT01776463
- Testing
- Z-360
- Where
- Japan
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Zeria Pharmaceutical
Healthy
Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food
Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level).
- Trial name
- NCT02229838
- Testing
- BIBB 1464 MS tablet, BIBB 1464 MS solution, Standard dinner
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Phase 1 Study of PROT-001.
A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Multi-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of PROT-001, the Effect of…
- Trial name
- NCT06981299
- Testing
- PROT-001, Rosuvastatin 10mg, Digoxin 0.25 mg
- Where
- Australia
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Protego Biopharma Pty Ltd
Pain, Acute, Acute Pain
Open-label, Crossover, Food Effect Study to Evaluate CT-044 in Healthy Human Volunteers
This open-label study will be conducted to assess the bioavailability and PK of oral single doses of CT-044 following administration with and without food and to evaluate the safety and tolerability of CT-044 when given with and…
- Conditions
- Pain, Acute, Acute Pain, Surgery, Neuropathy
- Trial name
- NCT04252833
- Testing
- CT-044
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Lotus Clinical Research, LLC
NAFLD
Study of the Safety and Tolerability of AXA1125 and AXA1957 in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
This is a randomized, single blind study to determine whether AXA1125 or AXA1957, novel compositions of amino acids, are safe and well tolerated.
- Trial name
- NCT04073368
- Testing
- AXA1957, AXA1125
- Where
- 18 sites in United States
- Volunteers
- 112 people
- Sponsor
- Axcella Health, Inc
Healthy Volunteers
Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study
The purpose of this study is to characterize the safety, tolerability and plasma pharmacokinetic (PK) profile of TAK-915 when administered as single and multiple oral suspension doses at escalating dose levels in healthy…
- Trial name
- NCT02461160
- Testing
- TAK-915 suspension, Midazolam, TAK-915 tablet
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteer
Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults
The purpose of the study is to evaluate the effects of a high fat meal on the pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.
- Trial name
- NCT01634178
- Testing
- Apremilast
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Amgen
Malaria
Safety, Tolerability, Pharmacokinetics, and Mosquitocidal Activity of Lotilaner in Healthy Participants in Mali.
This is a Phase 1b, single-cente, randomized, double-blind, placebo-controlled proof-of-concept study evaluating the safety, tolerability, pharmacokinetics and mosquitocidal activity of single oral doses of lotilaner in healthy…
- Trial name
- NCT07758985
- Testing
- Cohort 1 low dose lotilaner with a high-fat meal, Cohort 2 high dose lotilaner in fasted state, Cohort 3 high dose lotilaner with a high-fat meal
- Where
- Mali
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Peanut Allergy
Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy
This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.
- Trial name
- NCT05440643
- Testing
- Peanut SLIT-tablet
- Where
- 42 sites in United States, Canada
- Volunteers
- 209 people
- Sponsor
- ALK-Abelló A/S
Lipoprotein Disorder Disease
Safety and Tolerance of Increased Doses of HRS-5346 Tablets in Healthy Subjects
This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-5346 in healthy subjects, and to evaluate…
- Trial name
- NCT06441227
- Testing
- HRS-5346 tablets
- Where
- China
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
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 Adults
Study of XH-S003 in Healthy Volunteers
The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S003 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies.
- Trial name
- NCT06272747
- Testing
- XH-S003
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Peanut Allergy
Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who…
- Trial name
- NCT03793608
- Testing
- Dupilumab
- Where
- 9 sites in United States, Canada
- Volunteers
- 25 people
- Sponsor
- Regeneron Pharmaceuticals
Healthy
A Study to Investigate Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of JNJ-54175446 in Healthy Participants
The purpose of this study is to investigate the safety and tolerability of JNJ-54175446 versus placebo after single oral dose administration (ascending dose levels), to determine the maximal tolerated dose (MTD) or the safety and…
- Trial name
- NCT02475148
- Testing
- JNJ 54175446, High fat/high Calorie Breakfast
- Where
- Belgium
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Janssen-Cilag International NV