Clinical trials: Food Safety
Dyslipidemia
Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519(CKD-519 FDI)
The purpose this study investigate the effect of food on the pharmacokinetics/pharmacodynamics and safety of CKD-519
- Trial name
- NCT02484482
- Testing
- CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
- Where
- South Korea
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Cow's Milk Protein Allergy (CMPA)
TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)
This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed formula in young children aged 1~3 years with diagnosed with or highly suspected CMPA in a real-world clinical practice…
- Trial name
- NCT07855796
- Testing
- Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Teyi Yinuo Health Technology Co., Ltd.
HIV Infections
VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI)
This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants.
- Trial name
- NCT06533280
- Testing
- Part A, C and D: VH3739937 500 mg, Part A: VH3739937 100 mg, Part B: Treatment A
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Ulcerative Colitis (UC)
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally in Healthy Adult Participants and Patients With Active Ulcerative Colitis
A study to investigate the safety, tolerability, and pharmacokinetics (PK) of ONO-6414 orally in healthy adult participants and in patients with active ulcerative colitis (UC).
- Trial name
- NCT07749768
- Testing
- ONO-6414
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Healthy Volunteers and Diabetes Participants
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
This is a Phase 1/2 randomized study of oral doses of PAL-119 in healthy volunteers and participants with diabetes.
- Trial name
- NCT07901595
- Testing
- PAL-119
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Paulex Bio Inc.
Healthy
A Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-54416076 in Healthy Participants
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of JNJ-54416076 and any associated metabolite(s) (in Part 1) and safety, tolerability and PK of JNJ-54416076 when co administered with food…
- Trial name
- NCT02670395
- Testing
- JNJ-54416076
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Cow's Milk Protein Allergy (CMPA)
Safety and Efficacy Evaluation of an Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy (CMPA)
This is a prospective, multi-center, randomized, open-label, active-controlled, parallel-group, non-inferiority study. The goal of this clinical trial is to evaluate the clinical efficacy and safety of an extensively hydrolyzed…
- Trial name
- NCT07484035
- Testing
- Feihe Extensively Hydrolyzed Formula, Nestlé Extensively Hydrolyzed Formula
- Where
- 6 sites in China
- Volunteers
- 124 people
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Prader-Willi Syndrome, Obesity
Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome
The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adolescent and adult subjects with Prader-Willi Syndrome.
- Trial name
- bestPWS (NCT02179151)
- Testing
- ZGN-440 for Injectable Suspension
- Where
- 15 sites in United States
- Volunteers
- 108 people
- Sponsor
- Zafgen, Inc.
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.
Hereditary Angioedema
A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers
A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers.
- Trial name
- NCT04349800
- Testing
- KVD900
- Where
- United Kingdom
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Healthy Adult Subjects
ONO-7746 Study in Healthy Adult Subject
The primary objective of this study is to evaluate the safety and tolerability of NON-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746 and…
- Trial name
- NCT01106664
- Testing
- ONO-7746
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Atrial Fibrillation
Study to Assess the Safety, Tolerability, Pharmacokinetic of Thrv-1268
This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD).
- Trial name
- NCT06507839
- Testing
- THRV-1268
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Thryv Therapeutics, Inc.
Milk Allergy
Formula for Children With Cow's Milk Allergy
The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.
- Trial name
- NCT02317952
- Testing
- Experimental Extensively Hydrolyzed Formula, Active Comparator Formula
- Where
- 18 sites in United States
- Volunteers
- 90 people
- Sponsor
- Perrigo Nutritionals
Depressive Disorder
Food and Relative Bioavailability Study
This study is an open-label, randomised, single dose study to determine the pharmacokinetics, safety and tolerability of 2 different formulations of orvepitant 60 mg and the effect of food in 15 Healthy Volunteers.
- Trial name
- Food/rel BA (NCT00843011)
- Testing
- Orvepitant
- Where
- Italy
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Male Adults, Food Effect in Healthy Volunteers
A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants
This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male…
- Trial name
- NCT07549919
- Testing
- AJ201
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- AnnJi Pharmaceutical Co., Ltd.
Inflammatory Diseases
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy and Chronic Obstructive Pulmonary Disease Participants, to Assess the Relative Oral Bioavailability Between Two Formulations, and the Food Effect on the PK of AZD6793 Compared to Fasting State.
The purpose of the study is to assess the safety and tolerability of AZD6793 suspension following oral administration of Single Ascending Dose (SAD) [Part 1] and Multiple Ascending Dose (MAD) [Part 2] in healthy participants.
- Trial name
- NCT05662033
- Testing
- AZD6793
- Where
- 2 sites in United Kingdom
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Cachexia
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2849466 in Healthy Male Subjects
This study is the first administration of GSK2849466 in humans. This will be a single centre, randomized, double-blind, placebo-controlled study, to investigate the safety, tolerability, pharmacokinetics (PK), and…
- Trial name
- NCT01696604
- Testing
- GSK2849466
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Subjects
Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules
This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and…
- Trial name
- NCT06279533
- Testing
- LV232
- Where
- China
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Vigonvita Life Sciences
Cancer
Phase I Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of GSK2256098 in Healthy Volunteers
The purpose of this study is to test the safety of a new drug and to look at how the drug is handled by your body. This is the first time the drug will be given to people, the drug has been safely given to animals over many days…
- Trial name
- FTIH (NCT00996671)
- Testing
- GSK2256098
- Where
- Australia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
COVID-19 Respiratory Infection, FLU
Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients
The primary objective of this study is to determine the safety and efficacy profile of the food supplement (KUNAMIN®) containing grape juice, seed, stem, and bark given to patients treated with the established treatment regimen…
- Conditions
- COVID-19 Respiratory Infection, FLU, Cold; Influenza, Bacterial Pneumonia
- Trial name
- NCT05417997
- Testing
- Kunamin®, Favipiravir, Enoxaparin
- Where
- Turkey (Türkiye)
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- RAAS Nutritionals, LLC