Clinical trials: Food Safety
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.
Alzheimer Disease, Healthy Volunteers
Study of TAK-071 in Healthy Participants and Participants With Mild Cognitive Impairment/Mild Alzheimer Disease and Relative Bioavailability (BA) and Food Effect of TAK-071 in Healthy Participants
The purpose of this study was to assess the safety, tolerability, and pharmacokinetic (PK) of TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally in healthy participants and participants…
- Trial name
- NCT02769065
- Testing
- TAK-071, Donepezil
- Where
- United States
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Takeda
Hypercholesterolemia
Single Dose Study of PF-06815345 in Healthy Subjects
The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult…
- Trial name
- NCT02654899
- Testing
- PF-06815345
- Where
- Belgium
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Safety and Tolerability of Lu AG06474 in Healthy Young Men
The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.
- Trial name
- NCT05003687
- Testing
- Lu AG06474
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Food Effect Study of CJ-30056 20mg/500mg
The Food Effect on Pharmacokinetics and Safety of Fixed-dose Combination of CJ-30056 in Healthy Male Subjects
This study evaluate the food effect on pharmacokinetics and safety of fixed-dose combination of "CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)" in healthy male subjects
- Trial name
- NCT02160743
- Testing
- CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)
- Where
- South Korea
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants
This is a Phase 1, randomized, single-dose, double-blinded, 4-period, crossover study to evaluate the pharmacokinetics, safety, and tolerability of mitapivat in healthy adult participants under fasted and fed (high-fat meal)…
- Trial name
- NCT04472832
- Testing
- Mitapivat 100 mg, Mitapivat 300 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy
Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of BI 201335 NA and Bioavailability in Healthy Male Subjects
The objective of this study was to investigate the safety, tolerability, and pharmacokinetics of BI 201335 NA following administration of single rising doses from 4 mg to 1200 mg.
- Trial name
- NCT02182323
- Testing
- BI 201335 NA
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Parkinson Disease
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult Subjects
The Safety, Tolerability, Pharmacokinetic and Food Effect Study of HEC122505MsOH Tablets in Healthy Subjects
- Trial name
- NCT04625361
- Testing
- HEC122505MsOH
- Where
- China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Idiopathic Pulmonary Fibrosis
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNS-3545 in Healthy Participants
This is a randomized, double-blind, placebo-controlled Phase 1 study of SAD (Part 1) and MAD (Part 2) of orally administered GNS-3545 in healthy adult subjects. The food effect will be assessed in one cohort in Part 1.
- Trial name
- NCT07225296
- Testing
- GNS-3545
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Genosco Inc.
Overactive Bladder
A Two-Part Study to Determine: Best Medication Formulation and Food Effect
This is a two-part study. Part 1 is designed to find the best modified release formulation of GW423753; Part 2 is designed to use the selected formulation(s) from Part 1 to find out if food affects the way the medication is…
- Trial name
- NCT00427596
- Testing
- Solabegron
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study of LY4268989 (MORF-057) in Healthy Participants
The purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese…
- Trial name
- NCT06964776
- Testing
- LY4268989, Midazolam
- Where
- United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Participants
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State
This study will be conducted to determine the safety and tolerability of single and multiple oral ascending doses of AJM347 in healthy male participants, and to assess the pharmacodynamic response following single and multiple…
- Trial name
- NCT03133468
- Testing
- AJM347
- Where
- United Kingdom
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- EA Pharma Co., Ltd.
Diarrhea
Meatsafe Food Storage and Diarrhea Prevention Trial in Urban Bangladesh
The goal of this clinical trial was to evaluate whether a simple household food storage cabinet called a "meatsafe" could reduce bacterial contamination of complementary foods and decrease diarrhea among children aged 6 to 24…
- Trial name
- NCT07332078
- Testing
- Meatsafe Food Storage Cabinet
- Where
- Bangladesh
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley
Solid Tumors
The Study of BGB-283 in Chinese Subjects With Local Advanced or Metastatic Malignant Solid Tumor
This study will evaluate the safety, tolerability, pharmacokinetics, food effect, and preliminary antitumor activities of BGB-283 in Chinese subjects with local advanced or metastatic malignant solid tumor.
- Trial name
- NCT03641586
- Testing
- BGB-283
- Where
- China
- Volunteers
- 42 people
- Sponsor
- BeiGene
Bipolar Depression, Bipolar Disorder
Safety, Tolerability and Pharmacokinetics of Repeat Doses of GSK1014802.
GSK1014802 is a use-dependent sodium channel blocker and an effective anticonvulsant in animal models. This study is being conducted to obtain information regarding the safety, tolerability and pharmacokinetics of repeated doses…
- Trial name
- NCT00908154
- Testing
- GSK1014802
- Where
- United Kingdom
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Biogen
Food Allergies, Food Allergy in Children
Multi-Food Oral Immunotherapy for Peanut and Tree Nuts
This study aims to evaluate the efficacy and safety of multi-food oral immunotherapy (multi-OIT) using peanut and tree nuts proteins in children with confirmed food allergy to at least two allergens.
- Conditions
- Food Allergies, Food Allergy in Children, Peanut Allergies, Tree Nut Allergies
- Trial name
- NCT07764159
- Testing
- Multi-Food Oral Immunotherapy (Multi-OIT) with Peanut and Tree Nuts Proteins, Standard of Care (Elimination Diet)
- Where
- 4 sites in Poland
- Volunteers
- 39 people
- Sponsor
- Medical University of Warsaw
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)
Nonalcoholic Steatohepatitis (NASH)
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 on an empty stomach (fasted condition) and…
- Trial name
- NCT03392779
- Testing
- ZSP1601 25 mg, ZSP1601 50 mg, ZSP1601 100 mg
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Endometriosis
Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants
Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus.
- Trial name
- NCT05517746
- Testing
- BAY2395840 tablet, BAY2395840 oral solution
- Where
- Germany
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Bayer
Peanut Allergy, Milk Allergy, Cow's
Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety
Protocols for Oral Immunotherapy (OIT) for the main food allergens have been recently incorporated in clinical practice for food allergies and their clinical benefits have been acknowledged in European and Canadian official…
- Conditions
- Peanut Allergy, Milk Allergy, Cow's, Egg Allergy
- Trial name
- IMPROVES (NCT06256146)
- Testing
- Food allergy desensitization / Oral Immunotherapy
- Where
- Canada
- Volunteers
- 360 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre