Clinical trials: Food Safety
Healthy
Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males
Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (=…
- Trial name
- NCT02265302
- Testing
- BIIL 284 oral solution, BIIL 284 wetability improved formulation (WIF) tablets
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Anemia in Chronic Kidney Diseases
A Phase 1 Study of SSS17 in Healthy Subjects.
This study will investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of single oral administration of 5 mg, 15 mg, 20 mg and 25 mg of SSS17 compared with placebo, and evaluate the efficacy, safety, tolerance…
- Trial name
- NCT04893187
- Testing
- SSS17
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Healthy
Study of Danicopan in Participants of Japanese Descent
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.
- Trial name
- NCT04451434
- Testing
- Danicopan
- Where
- Australia
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Hepatitis B
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults
This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants.
- Trial name
- NCT04271592
- Testing
- ABI-H3733 Liquid Oral Dosage Form, ABI-H3733 Solid Oral Dosage Form
- Where
- New Zealand
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences
Peanut Allergy
Safety of MOON101 for the Treatment of Peanut Allergy
The goal of this open-label, single escalating dose study in 3 sequential groups: adults, adolescents, and children with peanut allergy is to assess the safety of MOON101. The main question it aims to answer is: 1.
- Trial name
- SURVEYOR (NCT07580898)
- Testing
- Dose A, Dose B, Dose C
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Moonlight Therapeutics, Inc.
Hypertension
Standardized Eucommia Extract in the Treatment of Hypertension
The purpose of this study is to demonstrate that eucommia, an herb used in China for making tea, is safe and effective for lowering blood pressure in humans with high blood pressure.
- Trial name
- NCT00626132
- Testing
- Eucommia
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Parkinson's Disease
Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202
The purpose of this study is to investigate the safety and tolerability of single oral rising doses of BIA 3-202 up to 800 mg (proposed doses 10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg) in groups of 9 healthy male…
- Trial name
- NCT02763787
- Testing
- BIA 3-202
- Where
- United Kingdom
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Prader-Willi Syndrome, Hyperphagia
Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).
- Trial name
- ZEPHYR (NCT03790865)
- Testing
- Livoletide
- Where
- 37 sites in United States, Australia and 6 more
- Volunteers
- 158 people
- Sponsor
- Millendo Therapeutics SAS
Cow's Milk Protein Allergy
Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides
The primary objective of the study is to show that infants with cow milk protein allergy (CMPA) fed with a new FSMP infant formula with reduced level of protein \& with 2 Human Milk Oligosaccharides (HMOs) (test formula) have a…
- Trial name
- CINNAMON (NCT03085134)
- Testing
- Test infant formula with HMOs, Control infant formula without HMOs
- Where
- 42 sites in Belgium, Hungary and 5 more
- Volunteers
- 194 people
- Sponsor
- Société des Produits Nestlé (SPN)
Dyslipidemia
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RS-C1001 Tablets in Chinese Healthy Subjects
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of RS-C1001 tablets in Chinese healthy subjects. This study will consist of two parts (Parts A and B).
- Trial name
- NCT06669429
- Testing
- RS-C1001
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Peking University First Hospital
Muscular Dystrophies
First Time in Human (FTIH) Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of GSK3439171A in Healthy Subjects and to Assess Food Effect
The FTIH study with GSK3439171A will evaluate the safety of GSK3439171A in healthy subjects in order to avoid confounding factors due to the disease or concomitant drugs in patients.
- Trial name
- NCT03627494
- Testing
- GSK3439171A
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Idiopathic Pulmonary Fibrosis
The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female Subjects
A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female…
- Trial name
- NCT03502902
- Testing
- HEC 68498
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Safety, Tolerability
A Clinical Trial to Investigate Safety and Tolerability of ASP7962 in Healthy Humans
The purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolized (chemically broken down), distributed through…
- Conditions
- Safety, Tolerability, Pharmacokinetics of ASP7962
- Trial name
- NCT01981928
- Testing
- ASP7962
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Drug Safety Biomarkers
Food-effect Study on Uracil and Dihydrouracil Levels as a Diagnostic Marker of Dihydropyrimidine Dehydrogenase Activity
Healthy volunteer food-effect study to determine the effect of food on uracil and dihydrouracil levels in plasma
- Trial name
- NCT02718664
- Testing
- Test meal (breakfast)
- Where
- Netherlands
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- The Netherlands Cancer Institute
Health Volunteer
Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RSS0343 Tablets in Healthy Subjects After Single and Multiple Oral Administration and the Effect of Food on the Pharmacokinetics of RSS0343
To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration
- Trial name
- NCT07101965
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Pharmacokinetics of ASP8477, Pharmacodynamics of ASP8477
A Study to Assess the Effects of Single Ascending Doses (SAD) of ASP8477, the Effect That Food Has on the Drug, and the Interaction Between ASP8477 and Omeprazole in Healthy Postmenopausal Females and Healthy Young Vasectomized Males
This is a 4-part study. Part I assesses the safety and tolerability of single ascending doses of ASP8477 or a placebo under fasted conditions in postmenopausal subjects.
- Trial name
- NCT02220777
- Testing
- ASP8477, omeprazole
- Where
- 2 sites in Belgium, France
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Tuberculosis, Tuberculosis, Pulmonary
A Phase 1 Study to Evaluate Safety, Tolerability, PK, and PK Interactions of TBA-7371
The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of TBA-7371 in healthy subjects
- Trial name
- NCT03199339
- Testing
- TBA-7371
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Healthy Volunteers
Effect of Food on the Pharmacokinetics of TEW-7197 in Healthy Subjects
Participants in this study will receive 200 milligram (mg) TEW-7197 taken at 7days apart. One dose will be given under fasting . The Other dose will be given with a high fat meal.
- Trial name
- NCT03704675
- Testing
- TEW-7197
- Where
- South Korea
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- MedPacto, Inc.
Healthy
A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects
The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male Japanese subjects.
- Trial name
- NCT02372344
- Testing
- AZD0585
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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