Clinical trials: Food Safety
Nonalcoholic Steatohepatitis (NASH)
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor.
- Trial name
- NCT02654002
- Testing
- Cilofexor
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Obesity; Overweight
Effect of GLP-1 Analogue ROSE-010 on Appetite in Overweight and Obese Subjects
The primary objective of this study is to assess the efficacy of ROSE-010 on food intake in female subjects with overweight and obesity.
- Trial name
- NCT06621017
- Testing
- ROSE-010 99 mcg, ROSE-010 150 mcg
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Rose Pharma Inc
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
Food Allergy
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
- Trial name
- NCT04856865
- Testing
- Low dose ADP101, High dose ADP101
- Where
- 15 sites in United States
- Volunteers
- 73 people
- Sponsor
- Alladapt Immunotherapeutics, Inc.
Healthy
A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People
The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is safe and how it goes in and out of the body in healthy people. PF-07817883 is for the potential treatment of COVID-19.
- Trial name
- NCT05580003
- Testing
- PF-07817883, Midazolam, Moxifloxacin
- Where
- 2 sites in United States, Belgium
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Pfizer
Malignant Melanoma
A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma
This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E…
- Trial name
- NCT01264380
- Testing
- RO5185426
- Where
- 10 sites in United States
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
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 Study
Study Investigating the Safety, Tolerability, PK and Food Effect of BEN8744.
BEN8744 is an experimental new medicine for treating inflammatory bowel diseases such as Ulcerative Colitis. The study will test single and repeated oral doses of BEN8744 or placebo.
- Trial name
- NCT06118385
- Testing
- BEN8744
- Where
- United Kingdom
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- BenevolentAI Bio
Eosinophilic Esophagitis, Milk Allergy
Milk Patch for Eosinophilic Esophagitis
This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis (EoE).
- Trial name
- SMILEE (NCT02579876)
- Testing
- Viaskin Milk 500 mcg
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital of Philadelphia
Autistic Disorder, Autism Spectrum Disorder
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants
This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD (Part 1) and MAD (Part 2)) and food effect (FE) of RO6953958 following oral…
- Conditions
- Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Mental Disorders
- Trial name
- NCT04475848
- Testing
- RO6953958, Midazolam
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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
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
Malaria
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533.
Phase 1, single -centre study in 2 parts. The study designs for each part are well established for first-in-human studies and are appropriate to assess safety, tolerability and preliminary pharmacokinetics.
- Trial name
- NCT04323306
- Testing
- MMV688533
- Where
- Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Cancer
Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)
The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose…
- Trial name
- NCT00306891
- Testing
- Cediranib, Cediranib 30 - 90 mg
- Where
- 4 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- AstraZeneca
Systemic Allergic Reaction
The Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose
Background: Some people have allergic reactions to COVID-19 mRNA vaccines. Researchers want to learn more about these reactions to provide guidance on who can safely receive the vaccines, including a second dose in people who had…
- Trial name
- NCT04977479
- Testing
- Pfizer-BioNTech COVID-19 Vaccine (Comirnaty), Pfizer-BioNTech COVID-19 Vaccine, Bivalent
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 474121, and Whether it Makes a Difference if BI 474121 is Taken as a Tablet or a Drink.
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 474121 in healthy male subjects following oral administration of single rising doses.
- Trial name
- NCT04194645
- Testing
- BI 474121 tablet, BI 474121 oral solution
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Peanut Allergy
The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy
The purpose of this study is to determine if a new method of administration of peanut sublingual immunotherapy, a dissolving peanut film, is effective.
- Trial name
- NCT01897077
- Testing
- Peanut Dissolving Film
- Where
- 2 sites in United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
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
Hyperkalemia
Patiromer With or Without Food for the Treatment of Hyperkalemia
The purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (QD) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high…
- Trial name
- TOURMALINE (NCT02694744)
- Testing
- patiromer
- Where
- 29 sites in United States
- Volunteers
- 114 people
- Sponsor
- Relypsa, Inc.