Clinical trials: Food Safety
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
Pharmacokinetics, Safety
JOTROL PK, Safety, and Food Effect Assessment
Type of Study: Single Ascending Doses (SAD) Study Objectives: To characterize the pharmacokinetic (PK) profile of JOTROL (resveratrol) following oral administration of SAD ranging from 200 mg up to a dose currently estimated at…
- Conditions
- Pharmacokinetics, Safety, Food-drug Interaction
- Trial name
- NCT04668274
- Testing
- 200 mg resveratrol as JOTROL, 500 mg resveratrol as JOTROL, 700 mg resveratrol as JOTROL
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Jupiter Orphan Therapeutics Inc.
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
Peanut Allergy
Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: To assess the efficacy of Viaskin Peanut after up to 36…
- Trial name
- OLFUS-VIPES (NCT01955109)
- Testing
- Viaskin Peanut 250 mcg
- Where
- 22 sites in United States, Canada and 2 more
- Volunteers
- 171 people
- Sponsor
- DBV Technologies
Healthy
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect study conducted at one study center in the United States.
- Trial name
- NCT03301298
- Testing
- SXC-2023
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Promentis Pharmaceuticals, Inc.
Autoimmune Diseases
A Study of the Safety, Tolerability, Pharmacokinetics and Food Effect After Single and Multiple Ascending Oral Doses
This is a Phase I Healthy volunteer study with the primary objective to evaluate the safety and pharmacokinetics profile of AX-158. The first part will evaluate single ascending dose administrations.
- Trial name
- NCT05218434
- Testing
- AX-158
- Where
- United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Artax Biopharma Inc
Healthy Volunteers
A Study of TAK-227 in Healthy Adults
The main aim of this study is to test the effects of food consumption with sponsor compound TAK-227 in healthy participants. The study will also measure side effects, and to check how much TAK-227 stays in the blood over time to…
- Trial name
- NCT05818956
- Testing
- TAK-227
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Takeda
Advanced Solid Malignancy,, Safety and Tolerability,
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
- Conditions
- Advanced Solid Malignancy,, Safety and Tolerability,, Pharmacokinetics, Pharmacodynamics,, Tumour Response,
- Trial name
- OAK (NCT01895946)
- Testing
- AZD5363
- Where
- 3 sites in Netherlands, United Kingdom
- Volunteers
- 33 people
- Sponsor
- AstraZeneca
Prader-Willi Syndrome, Hyperphagia
Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).
- Trial name
- ZEPHYR (NCT03790865)
- Testing
- Livoletide
- Where
- 37 sites in United States, Australia and 6 more
- Volunteers
- 158 people
- Sponsor
- Millendo Therapeutics SAS
Muscular Dystrophies
First Time in Human (FTIH) Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of GSK3439171A in Healthy Subjects and to Assess Food Effect
The FTIH study with GSK3439171A will evaluate the safety of GSK3439171A in healthy subjects in order to avoid confounding factors due to the disease or concomitant drugs in patients.
- Trial name
- NCT03627494
- Testing
- GSK3439171A
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
This Study in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood.
The primary objective of the single-rising dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730460 in healthy subjects following oral administration of single rising doses.
- Trial name
- NCT03483077
- Testing
- BI 730460
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Inflammatory Bowel Diseases
Phase 1 Study for IPG11406 in Health Volunteer
A phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and food effect of orally administered IPG11406 in healthy adult…
- Trial name
- NCT06255834
- Testing
- IPG11406
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Nanjing Immunophage Biotech Co., Ltd
Healthy Volunteers, Schizophrenia
Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of TAK-041: 1. Following oral single and multiple doses in healthy participants. 2.
- Trial name
- NCT02748694
- Testing
- TAK-041
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood
SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the…
- Trial name
- NCT04445090
- Testing
- BI 1569912
- Where
- Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Food Allergy
Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy
The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the…
- Trial name
- MILES (NCT02223182)
- Testing
- Viaskin Milk 150 mcg, Viaskin Milk 300 mcg, Viaskin Milk 500 mcg
- Where
- 17 sites in United States, Canada
- Volunteers
- 198 people
- Sponsor
- DBV Technologies
Peanut Allergy
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing…
- Trial name
- NCT03682770
- Testing
- Dupilumab, AR101
- Where
- 25 sites in United States
- Volunteers
- 148 people
- Sponsor
- Regeneron Pharmaceuticals
Allergy, Peanut
Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts.
- Trial name
- NCT05432388
- Testing
- LOU064
- Where
- 24 sites in United States
- Volunteers
- 76 people
- Sponsor
- Novartis Pharmaceuticals
Cyclic Vomiting Syndrome
Staccato Granisetron® (AZ 010) for the Treatment of Cyclic Vomiting Syndrome
This is a multicenter, randomized, double-blind, parallel group, placebo-controlled, efficacy and safety study of adult outpatients diagnosed with CVS and experiencing recurring episodes of stereotypical vomiting.
- Trial name
- NCT04645953
- Testing
- 3mg AZ-010, 1mg AZ010
- Where
- 18 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Alexza Pharmaceuticals, Inc.
Plaque Psoriasis
A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation
The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when administered to humans. A secondary purpose is to assess what the body does to PF-06700841 and to assess what PF-06700841 does to the…
- Trial name
- NCT02310750
- Testing
- PF-06700841 oral solution/suspension, PF-06700841 tablet
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of single rising doses.
- Trial name
- NCT03794323
- Testing
- BI 764122
- Where
- Belgium
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim