Clinical trials: Food Safety
Allergies Food Milk
Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy
This is a phase 2, multicenter, randomized, double-blind, parallel group, 2 arm study in approximately 40 subjects aged 4 to 50 years, inclusive, who are allergic to cow's milk.
- Trial name
- NCT04148352
- Testing
- Dupilumab
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Andrew J Long, PharmD
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
To Assess Safety, Tolerability and Pharmacokinetics of BI 730357 in Healthy Male Volunteers
The primary objective of the Single Rising Dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730357 in healthy subjects following oral administration of single rising doses after fasting and/or…
- Trial name
- NCT03004404
- Testing
- BI 730357
- Where
- Germany
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Peanut Allergy
Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous…
- Trial name
- PEPITES (NCT02636699)
- Testing
- Viaskin Peanut 250mcg
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 500 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.
Healthy Volunteers, Insulin Resistance
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect of KQ-791
The purpose of this study is to assess the safety, tolerability, and the effect of food on KQ-791. Each participant may receive up to 3 single doses of KQ-791 (at up to 3 different dose levels) and 1 placebo dose over the course…
- Trial name
- NCT02370043
- Testing
- KQ-791, KQ-791 (after meal)
- Where
- 2 sites in Canada
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Kaneq Bioscience Limited
Healthy Participants
A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants.
The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixorafenib in healthy participants.
- Trial name
- NCT06385119
- Testing
- Plixorafenib, Cobicistat
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Fore Biotherapeutics
Peanut Allergy
Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
The objectives of this dose-finding study for the treatment of peanut allergy are: To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize…
- Trial name
- VIPES (NCT01675882)
- Testing
- Viaskin Peanut 50 mcg, Viaskin Peanut 100 mcg, Viaskin Peanut 250 mcg
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 221 people
- Sponsor
- DBV Technologies
Respiratory Syncytial Viruses
A Study to Assess the Safety, Effects and Palatability of Sisunatovir in Healthy Adult Participants
This study is seeking healthy participants who are: 1. Aged 18 to 65 years of age. All fertile participants must agree to use a highly effective method of contraception. 2.
- Trial name
- NCT05712460
- Testing
- sisunatovir
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Nonhematologic Malignancies, Lymphoma
Pharmacokinetics Study of Oral IXAZOMIB in Participants With Advanced Nonhematologic Malignancies or Lymphoma
This is an open-label, multicenter, sequential, 5-arm, phase 1 study of oral IXAZOMIB designed to assess drug-drug interaction with ketoconazole (Arm 1), the relative bioavailability of 2 capsule formulations of IXAZOMIB (Arm 2)…
- Trial name
- NCT01454076
- Testing
- Ixazomib 2.5 mg, Ixazomib 4 mg Capsule A, Ixazomib 4 mg Capsule B
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Hypertension and Chronic Heart Failure
Safety, Tolerability, Pharmacokinetic, Including Food Interaction, and Pharmacodynamic Profile of BIA 5-1058.
The purpose of this study is to to assess the safety and tolerability of BIA 5 1058 after single and multiple oral doses
- Trial name
- NCT02151994
- Testing
- BIA 5-1058
- Where
- Netherlands
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
HIV Infections
A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants
This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and GSK3640254 mesylate capsules (in the presence of a moderate…
- Trial name
- NCT04128293
- Testing
- GSK3640254 Tablet, GSK3640254 Capsule
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Malaria,Falciparum
First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV367
This three-part, first-in-human, healthy volunteer study aims to assess the safety and tolerability of the test medicine as well as how it is taken up by the body when given as single and multiple doses.
- Trial name
- NCT05507970
- Testing
- MMV367, MMV367 (Fed 440mg), MMV367 (Fasted 440mg)
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
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
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.
Healthy
Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects
Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects
- Trial name
- NCT03123185
- Testing
- BI 705564 (Test), BI 705564 (Reference)
- Where
- Germany
- Volunteers
- 91 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
Tuberculosis
Safety, Tolerability, Pharmacokinetics (PK), and Food Effect of MK-7762 in Healthy Adults
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of single and then multiple doses of MK-7762 (TBD09) in healthy volunteers in the context of a first-in-human study.
- Trial name
- NCT05824091
- Testing
- MK-7762 (TBD09)
- Where
- United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Healthy Volunteer
Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults
The primary objective of Part 1 of the study is to evaluate the safety and tolerability of S-648414 after administration of a single oral dose of S-648414 in healthy adult study participants.
- Trial name
- NCT04147715
- Testing
- S-648414, Midazolam, Dolutegravir
- Where
- 2 sites in United States, Japan
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Shionogi