Clinical trials: Food Safety
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
Healthy
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects
This first-in-human study has three parts. In Parts A and B, the safety, tolerability, and pharmacokinetics (PK) will be evaluated following administration of single and multiple doses of KRP-A218, including food-effect.
- Trial name
- NCT04908800
- Testing
- KRP-A218, itraconazole
- Where
- United Kingdom
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Kyorin Pharmaceutical Co.,Ltd
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
Non-Alcoholic Fatty Liver Disease, Liver Fibrosis
Study in Healthy Adults Evaluating PF-07202954
The study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).
- Trial name
- NCT04857437
- Testing
- PF-07202954 Repeat Dose, PF-07202954 Single Dose
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Erectile Dysfunction
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.
- Trial name
- NCT01254396
- Testing
- Sildenafil
- Where
- Singapore
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy Volunteers
A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults
The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body.
- Trial name
- NCT06268301
- Testing
- Budesonide
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Takeda
Infection, Human Immunodeficiency Virus, HIV Infections
A Two-part Study to Compare a Tablet and Capsule Formulation of GSK2838232 With and Without Food, and to Assess the Safety and Drug Levels of Repeated Once-daily Doses of GSK2838232 Without Ritonavir
This study will be conducted in two Parts to confirm the acceptability/selection of a tablet formulation for future clinical development of GSK2838232.
- Trial name
- NCT03234036
- Testing
- GSK2838232 100 mg tablet, GSK2838232 50 mg capsule, Ritonavir 100 mg tablets
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Malaria
A FIH Study to Investigate the Safety, Tolerability and PK of P218
The First in Human (FIH) study is separated into two parts: The first part is a Single Ascending Dose (SAD), double-blinded, randomized and placebo-controlled, including 8 cohorts of 8 subjects (2 placebo and 6 on active drug).
- Trial name
- NCT02885506
- Testing
- Oral administration of P218 capsules
- Where
- United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
NAFLD
Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
This is a randomized, single blind study to determine whether AXA1957, a novel composition of amino acids, is safe and well tolerated.
- Trial name
- NCT04073407
- Testing
- AXA1957
- Where
- 4 sites in United Kingdom
- Volunteers
- 9 people
- Sponsor
- Axcella Health, Inc
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
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
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
Study of Single and Multiple Ascending Doses of PF-07059013 in Healthy Adult Participants
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) of single and multiple ascending oral doses of PF-07059013 in healthy adult participants.
- Trial name
- NCT04323124
- Testing
- PF-07059013
- Where
- Belgium
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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
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
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.
Healthy
A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood
The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI…
- Trial name
- NCT05945888
- Testing
- BI 3000202
- 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