Clinical trials: Food Safety
Healthy
This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Looks at How Food Influences the Amount of BI 1358894 in the Blood
The primary objective of this trial is to investigate the safety and tolerability of BI 1358894 in healthy male subjects following oral administration of single rising doses.
- Trial name
- NCT03210272
- Testing
- BI 1358894, BI 1358894 (Test), BI 1358894 (Reference)
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Peanut Allergy
The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery
Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed after the initial 3 month avoidance period Secondary Objectives: Identify the basic immune mechanisms which can explain the differences in…
- Trial name
- POISED (NCT02103270)
- Testing
- Peanut Protein 4,000mg, Oat Flour, Peanut Protein 300 mg
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Stanford University
Safety, Bioavailability
Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a…
- Conditions
- Safety, Bioavailability, Pharmacokinetics
- Trial name
- BA (NCT05627518)
- Testing
- Linaprazan glurate
- Where
- Slovenia
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
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)
Egg Allergy
Safe Administration of Flu Vaccine to Egg Allergic Children
Historically, providing influenza vaccination of egg allergic children and young adults (EAC) with a history of anaphylaxis to egg, or other severe symptoms of an allergic reaction to egg (e.g., severe hives, swelling, or…
- Trial name
- SAFE (NCT01264601)
- Testing
- Trivalent Influenza Vaccine
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- University of Michigan
Urinary Tract Infections
Safety, Tolerability and Pharmacokinetic Investigation of GSK3882347 in Healthy Participants.
This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, first time in human (FTIH) study, that includes both single-ascending and multiple-ascending dose phase to assess the safety…
- Trial name
- NCT04488770
- Testing
- GSK3882347
- Where
- United Kingdom
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
HIV
Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women
This study will inform international medical guidelines as to whether the Levonorgestrel intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive method, is safe and acceptable as compared to the…
- Trial name
- NCT01721798
- Testing
- Mirena levonorgestrel IUD, Copper T-380a IUD
- Where
- South Africa
- Volunteers
- 199 people, healthy volunteers welcome
- Sponsor
- FHI 360
Hypertension
8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension
The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.
- Trial name
- NCT01570686
- Testing
- Aliskiren
- Where
- 83 sites in United States, Canada and 5 more
- Volunteers
- 589 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Attention Deficit Hyperactivity Disorder
Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)
This study evaluated the safety and clinical effect of treatment with methylphenidate under different breakfast conditions (minimal breakfast versus standard continental breakfast) in children with Attention-Deficit Hyperactivity…
- Trial name
- NCT00428792
- Testing
- Methylphenidate 20 mg long-acting capsules
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Novartis
Peanut Allergy
Safety Study of Viaskin Peanut to Treat Peanut Allergy
This study evaluates the safety of Viaskin Peanut 250 µg in the treatment of peanut allergy in children from 4 to 11 years of age.
- Trial name
- REALISE (NCT02916446)
- Testing
- Viaskin Peanut 250 µg
- Where
- 32 sites in United States, Canada
- Volunteers
- 393 people
- Sponsor
- DBV Technologies
Acne
ABSORICA in Patients With Severe Recalcitrant Nodular Acne
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne.
- Trial name
- NCT02457520
- Testing
- Isotretinoin
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Advanced Solid Tumors
Study of MLN8237 in Participants With Advanced Solid Tumors
The purposes of this study were to estimate the relative (Rel) bioavailability (BA) of an oral solution (OS) formulation of alisertib in reference to a powder-in-capsule (PIC) formulation, to characterize the effect of food on…
- Trial name
- NCT00962091
- Testing
- Alisertib
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Safety, Pharmacokinetics, Pharmacodynamics, Food Effect
Single + Multiple Ascending Dose and Food Effect Study of AZD7986 in Healthy Volunteers, PK, PD and Safety Study
This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of AZD7986 in healthy volunteers
- Trial name
- NCT02303574
- Testing
- AZD7986, oral solution, 1 to 50 mg/mL
- Where
- United Kingdom
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Allergy, Peanut
Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
This was a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) SC q4w (subcutaneous injection…
- Trial name
- NCT04984876
- Testing
- ligelizumab
- Where
- 55 sites in United States, Australia and 8 more
- Volunteers
- 211 people
- Sponsor
- Novartis Pharmaceuticals
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