Clinical trials: Food Safety
Ischemic Stroke
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and Food Effects of DA414 Granules in Chinese healthy subjects with single and multiple doses.
- Trial name
- DA414 (NCT06525168)
- Testing
- DA414 Granules
- Where
- China
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Chendu DIAO Nine Hong Pharmaceutical Factory
Solid Tumor, Obesity
Study of Single and Multiple Oral Doses of SCB0020160 in Healthy Adult Male Subjects
This study aims to evaluate the safety, tolerability, pharmacokinetics, and food effect of a new investigational medicine called SCB0020160 in healthy adult men. This is the first time SCB0020160 will be administered to humans.
- Conditions
- Solid Tumor, Obesity, Idiopathic Pulmonary Fibrosis
- Trial name
- NCT07682337
- Testing
- SCB0020160
- Where
- Australia
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- SCBIO Inc.
Pharmacokinetics of ASP4058, Healthy Subjects
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP4058 Following Single Oral Doses
The purpose of this study is to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP4058 in non-elderly, healthy male and female subjects.
- Conditions
- Pharmacokinetics of ASP4058, Healthy Subjects, Food Effect of ASP4058
- Trial name
- NCT01998646
- Testing
- ASP4058
- Where
- 2 sites in United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Overweight
Safety Evaluation and Effect of Food Supplement Containing Dietary Fiber From Cassava on the Alterations of Physiological Parameters in Overweight Female Volunteers
This study is set up to determine the consumption safety and the effect of a food supplement containing dietary fiber from cassava on the alterations of physiological parameters including fasting blood sugar, HbA1c, insulin…
- Trial name
- NCT04013490
- Testing
- Cassava dietary fiber capsule
- Where
- Thailand
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Khon Kaen University
Hepatitis B
A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants
This is a Phase 1 first-in-human (FIH) study evaluating single and multiple dose administration of AL-034 in healthy adult participants.
- Trial name
- NCT03285620
- Testing
- AL-034
- Where
- New Zealand
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Endometriosis
A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219
This is a randomised, double-blind, placebo-controlled, Phase I/Ib study which will assess the safety, tolerability, food effect, pharmacokinetics and pharmacodynamics of FOR-6219, a hydroxysteroid (17B) dehydrogenase (HSD17B1)…
- Trial name
- NCT03709420
- Testing
- FOR-6219
- Where
- United Kingdom
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Forendo Pharma Ltd
Type II Diabetes Mellitus
Study to Evaluate the Food Effect on Pharmacokinetics Profile and Safety of CKD-393
Study to evaluate the food effect on pharmacokinetic profiles and safety of CKD-393 in healthy volunteers
- Trial name
- NCT05274880
- Testing
- CKD-393
- Where
- South Korea
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy Volunteers, Atopic Diathesis and Atopic Dermatitis
Single Dose and Multiple Dose Study to Assess Safety and Tolerability of LOU064
This is a 6-part first-in-human study in up to approximately 184 participants. Parts 1 to 5 is in health volunteers and part 6 is in subjects with atopic dermatitis.
- Trial name
- NCT03918980
- Testing
- LOU064
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Young Volunteers, Healthy Elderly Volunteers
A Single Dose Study to Assess the Safety, Effects, and Blood and Urine Drug Levels of AZD3293 in Healthy Subjects
This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293.
- Trial name
- NCT01739647
- Testing
- AZD3293
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Chronic Hepatitits C
First in Human Study of AL-704; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part study in which the safety, tolerability, and pharmacokinetics of orally administered AL-704 will be assessed in healthy adult subjects and in…
- Trial name
- NCT02510248
- Testing
- AL-704
- Where
- 3 sites in France, Georgia and 1 more
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Healthy Participants, IBD (Inflammatory Bowel Disease)
A Phase I Study of HW201877 in Healthy Subjects
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single…
- Trial name
- NCT07373457
- Testing
- HW201877 capsules
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Weight Gain
Food Replacement on Weight Control in Overweight Volunteers
Volunteers will be divided into two groups which are protein and oil supplement group and normal dietary group. For protein and oil supplement group, they will take 1 sachet of product replaced dinner every day for 8 weeks.
- Trial name
- NCT06488339
- Testing
- Protein and oil supplement
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Advanced Non-Central Nervous System (CNS) Malignancies
A Phase 1 Study of Oprozomib to Assess Food Effect, Drug-Drug Interaction With Midazolam, and Safety and Tolerability in Patients With Advanced Malignancies
The purpose of this Phase 1 of the study is to evaluate the effect of food on the pharmacokinetics (PK) of oprozomib, the drug-drug interaction of oprozomib with midazolam, and the safety and tolerability of oprozomib in patients…
- Trial name
- NCT02244112
- Testing
- Oprozomib, Midazolam
- Where
- 7 sites in United States
- Volunteers
- 43 people
- Sponsor
- Amgen
Healthy Adult Male and Female Volunteers
A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years
Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.
- Trial name
- NCT07413666
- Testing
- ORX489 Tablets
- Where
- United States
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Malaria
A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat Malaria
The purpose of this study is to determine if the study drug (antimalarial medication) is safe when given to healthy subjects as a single dose or as repeated doses, to understand the effect of food on single doses of study drug…
- Trial name
- NCT00811356
- Testing
- GSK932121; Rosiglitazone; Rosuvastatin
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
NEC, Gastroschisis
Neokare Safety and Tolerability Assessment in Neonates With GI Problems
With an increasing body of evidence to support a causal link between drinking milk that contain cow's milk protein (CMP) and the development of gastrointestinal disturbance in infants, many clinicians avoid the use of CMP…
- Conditions
- NEC, Gastroschisis, Intestinal Perforation, Atresia, Intestinal
- Trial name
- NCT05293353
- Testing
- NeoKare Breast Milk Fortifier
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Type 2 Diabetes Mellitus (T2DM)
Clinical Study to Evaluate the Food Effect of CKD-383 0.5/10/1000mg in Healthy Volunteers
This study is a randomized, open-label, single dose, crossover study to evaluate the food effect of CKD-383 in healthy volunteers
- Trial name
- CKD-383 FDI P1 (NCT06695572)
- Testing
- CKD-383
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Pulmonary Hypertension
Preliminary Human Trials of F230 Tablets
F230 is a new Class 1 chemical drug jointly developed by Beijing Contini Pharmaceutical Co., Ltd. for the treatment of pulmonary hypertension (Notification number: 2024LP01242, 2024LP01243).
- Trial name
- NCT06899815
- Testing
- F230 tablets
- Where
- China
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Acne
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of…
- Trial name
- NCT06989840
- Testing
- TVB-3567
- Where
- 6 sites in United States, Australia
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Sagimet Biosciences Inc.
Diabetes Mellitus
Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects
The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251…
- Trial name
- NCT02106585
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Shionogi Inc.