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
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
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
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
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
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.
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