Clinical trials: Food Safety
Health
A Single and Multiple Dose Study to Explore the Safety Of JNJ-40346527 In Healthy Volunteers
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single and…
- Trial name
- NCT01054014
- Testing
- JNJ-40346527
- Where
- Belgium
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Food Allergy
Safety of Oral Food Challenge With Cow's Milk Proteins in Children With Food Allergy
The aim of the study is to assess the safety of an oral food challenge (OFC) with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with a food allergy after introducing cow's milk into the diet.
- Trial name
- NCT04312438
- Testing
- oral food challenge with cow's milk proteins
- Where
- Poland
- Volunteers
- 1 people
- Sponsor
- Wroclaw Medical University
Healthy
A Single and Multiple Dose of Rodatristat Ethyl in Healthy Adult Subjects to Evaluate the Effect of Food and Safety
This is a single and multiple dose food effect study of rodatristat ethyl in healthy subjects
- Trial name
- NCT05684640
- Testing
- Rodatristat Ethyl
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Altavant Sciences GmbH
Healthy Volunteers
Single and Multiple Ascending Dose Study of AMG 378 in Healthy Participants
The main objective of the study is to assess the safety and tolerability of AMG 378 as single or multiple doses in healthy participants.
- Trial name
- NCT06910709
- Testing
- AMG 378
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amgen
Food-Drug Interactions
Hop Botanical Dietary Supplements - Metabolism and Safety in Women
Human safety studies were carried out to test whether hop botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs.
- Trial name
- NCT02848430
- Testing
- Humulus lupulus
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
Hepatitis B, Chronic
EYP001a Food Effect Study in Subjects With Chronic Hepatitis B Virus (HBV) Infection
The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B.
- Trial name
- NCT03320616
- Testing
- EYP001a
- Where
- Netherlands
- Volunteers
- 11 people
- Sponsor
- Enyo Pharma
Healthy
Oral Bioavailability,and Food Effect Study and Single Ascending Dose PK Study in Healthy Male Volunteers
This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study.
- Trial name
- NCT03372239
- Testing
- Indoximod base formulation, Indoximod HCL (salt) formulation
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- NewLink Genetics Corporation
Healthy Human Volunteers
Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy Volunteers
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple doses of XPF-001 in healthy volunteers. The effect of food on the pharmacokinetics of XPF-001 will also be studied.
- Trial name
- NCT00813670
- Testing
- XPF-001
- Where
- Canada
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Xenon Pharmaceuticals Inc.
Safety Issues
Safety Evaluation of Porous Silica in Men
The aim of the present study was to determine whether oral dosing, up to 9 grams/day, of porous silica administered as a food additive can be used safely in normal weight and obese male humans, without significant side effects on…
- Trial name
- NCT03667430
- Testing
- Porous silica
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Karolinska Institutet
Hepatitis C, Chronic
First in Human Study of ALS-002200; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered ALS-002200 in healthy volunteers (HV) and subjects with chronic hepatitis C (CHC)…
- Trial name
- NCT01590407
- Testing
- ALS-002200
- Where
- 4 sites in France, Moldova and 1 more
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Nonalcoholic Steatohepatitis (NASH)
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor.
- Trial name
- NCT02654002
- Testing
- Cilofexor
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Primary Liver Cancer
Effect of Food and Formulation on the Pharmacokinetics, Safety, and Tolerability of GNS561 After One Single Dose (50 and 200mg) in Healthy Volunteers
GNS561 is a drug used in preliminary phase 1b study for treatment of patients with primary and secondary liver cancer. The formulation used was oral capsule.The objective of this study in healthy volunteers is to compare…
- Trial name
- NCT05353894
- Testing
- GNS561 oral tablets and capsules
- Where
- France
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Genoscience Pharma
COVID-19
GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy Subjects
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of GS-441524 in healthy subjects. The main questions to answer are: 1) What dosage of GS-441524 is required for adequate therapeutic…
- Trial name
- NCT06274853
- Testing
- GS-441524
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Center for Advancing Translational Sciences (NCATS)
Healthy
A Study of IBI3032 in Chinese Healthy Subjects
This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, PK and food effect of a single dose of IBI3032 in healthy participants.
- Trial name
- NCT07134127
- Testing
- IBI3032
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)
Safety
Single Dose and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4
A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. Cohorts of healthy adults (female and male) will participate in: single dose escalation study of increasing doses of MRX-4…
- Trial name
- NCT03033342
- Testing
- Oral single doses of MRX-4, Oral multiple doses of MRX-4, MRX-4 co-administered with omeprazole
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- MicuRx
Food Allergy
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy.
- Trial name
- NCT06261554
- Testing
- Dietary Supplement: Low dose OIT
- Where
- Poland
- Volunteers
- 39 people
- Sponsor
- Medical University of Warsaw
Chronic Kidney Disease
Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects
This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate…
- Trial name
- NCT05638126
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Infections, Bacterial
Single Dose Escalation First Time in Human PK Study
This is a first time in human (FTIH) study of single escalating doses of investigational study drug to investigate safety, tolerability, and pharmacokinetics in healthy subjects
- Trial name
- NCT00828867
- Testing
- 100 mg GSK investigational drug, 200 mg GSK investigational drug, 400 mg GSK investigational drug
- Where
- Australia
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
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.