Clinical trials: Food Safety
cMET Dysegulation Advanced Solid Tumors
A Dose Escalation Study to Assess PK, Safety and Tolerability of INC280 When Taken With Food in cMET Dysregulated Advanced Solid Tumors.
Dose escalation study to assess PK, safety and tolerability of INC280 when taken with food in patients with cMET dysregulated advanced solid tumors.
- Trial name
- NCT02925104
- Testing
- INC280
- Where
- 17 sites in United States, Austria and 6 more
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Healthy, Renal Impairment
A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment
A phase 1 clinical trial to evaluate safety, PK/PD profiles and food effects of URC102 in patients with renal impairment and healthy people.
- Trial name
- NCT05198778
- Testing
- URC102
- Where
- 2 sites in South Korea
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- JW Pharmaceutical
HCV Infection
Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
The purpose of this study is to evaluate the effect of food on pharmacokinetics, safety and tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in healthy volunteers.
- Trial name
- NCT00909311
- Testing
- ABT-450, ritonavir
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Abbott
Obesity
A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect of HSG4112 in High Doses
1. Study Objective i) To evaluate the safety, tolerability and pharmacokinetic/pharmacodynamic characteristics of HSG4112 after single and multiple oral administration of high doses in healthy subjects.
- Trial name
- NCT05310032
- Testing
- HSG4112
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Glaceum
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
Single-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-281959 / ACT-246475 in Healthy Male Subjects
Study Part I is a single-ascending dose study. Healthy male subjects to be included in the study and randomized in 6 dose groups, Groups A-F (8 subjects per group).
- Trial name
- NCT01954615
- Testing
- 5 mg ACT-281959 prodrug formulation I (Group A), 20 mg ACT-281959 prodrug formulation I (Group B), ACT-281959 prodrug formulation I (Groups C to G doses to be defined)
- Where
- France
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Phase 1
The Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects
This is a study to evaluate the safety, tolerability, pharmacokinetics, and food effects of SHEN211 tablet in healthy subjects after fasting single or multiple oral administration
- Trial name
- NCT06214858
- Testing
- SHEN211 tablets
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- JKT Biopharma Co., Ltd.
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.
Healthy, Pharmacokinetics of ASP0456
A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects
A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending dose of ASP0456 in non-elderly healthy subjects.
- Trial name
- NCT01427387
- Testing
- ASP0456
- Where
- Japan
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Food-drug Interaction
Licorice Botanical Dietary Supplements - Metabolism and Safety in Women
Human safety studies will be carried out to test whether red clover botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs.
- Trial name
- NCT03948243
- Testing
- Licorice, Alprazolam 2 MG, Caffeine 100 MG
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
Solid Tumor
To Evaluate the Safety, Pharmacokinetic and the Effect of Food After Administration of ABN401 in Healthy Adult Volunteers
This randomized open-label, two-way crossover study is designed to evaluate the safety and pharmacokinetic characteristics of ABN401, and the effect of high-fat meal on the pharmacokinetic profiles of ABN401 and its metabolites…
- Trial name
- NCT05248074
- Testing
- High-fat meal (over 900 kcal), ABN401 (investigational product)
- Where
- South Korea
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Abion Inc
Healthy Volunteers, Insulin Resistance
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect of KQ-791
The purpose of this study is to assess the safety, tolerability, and the effect of food on KQ-791. Each participant may receive up to 3 single doses of KQ-791 (at up to 3 different dose levels) and 1 placebo dose over the course…
- Trial name
- NCT02370043
- Testing
- KQ-791, KQ-791 (after meal)
- Where
- 2 sites in Canada
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Kaneq Bioscience Limited
Cancer
Examining the Feasibility and Impact of a Clinic-based Food Farmacy and Digital Culinary Medicine Program Among Cancer Survivors Treated in a Safety Net Hospital
The goal of this study is to develop and test the feasibility of a theory-driven digital culinary medicine program among food insecure cancer survivors referred from the University of Texas MD Anderson Cancer Center Oncology…
- Trial name
- NCT06760754
- Testing
- Digital culinary medicine intervention
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- M.D. Anderson Cancer Center
Respiratory Tract Infection, Infections, Bacterial
A Three-Part Study Of GSK580416 In Healthy Subjects
Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans.
- Trial name
- NCT00427141
- Testing
- GSK580416
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Food Allergy in Children, Cow Milk Allergy
Nutrition Sufficiency, Allergy Efficacy and Safety of Neocate Jr in Children With Food Protein Allergy
The main purpose of this study is to evaluate efficacy and safety of an amino acid-based formula Neocate Jr in children with food protein allergy, and to evaluate nutrition sufficiency of Neocate Jr in 1 to 10 years old children…
- Trial name
- NCT05406141
- Testing
- Amino acid formula (Neocate Jr)
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Peking University Third Hospital
Advanced Solid Malignancy,, Safety and Tolerability,
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
- Conditions
- Advanced Solid Malignancy,, Safety and Tolerability,, Pharmacokinetics, Pharmacodynamics,, Tumour Response,
- Trial name
- OAK (NCT01895946)
- Testing
- AZD5363
- Where
- 3 sites in Netherlands, United Kingdom
- Volunteers
- 33 people
- Sponsor
- AstraZeneca
Peanut Allergy
Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous…
- Trial name
- PEPITES (NCT02636699)
- Testing
- Viaskin Peanut 250mcg
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 500 people
- Sponsor
- DBV Technologies
Healthy Volunteer
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers
This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers.
- Trial name
- NCT01461967
- Testing
- RO5508887
- Where
- France
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Toxicity, Healthy
A Study of GFH312 in Healthy Subjects
GFH312 is a small molecule inhibitor of receptor-interacting serine/threonine protein-1(RIP1) kinase, a key regulator of the TNF-α downstream.
- Trial name
- NCT04676711
- Testing
- GFH312
- Where
- Australia
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- GenFleet Therapeutics (Australia) Pty Ltd.
Muscular Atrophy, Spinal
Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants
The study is a randomized, single oral dose, crossover study in up to three parts to investigate the relative bioavailability and bioequivalence of two different formulations of risdiplam 5 mg (dispersible tablets) versus the…
- Trial name
- NCT04718181
- Testing
- risdiplam, omeprazole
- Where
- 4 sites in United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Aging, Mitochondrial Dysfunction
A Single and Multiple Dose Study of AMAZ-02 to Evaluate Safety and Pharmacokinetics in Elderly Subjects
Part A: The study is a double-blind, randomized, single ascending doses, study in 24 healthy elderly male and female volunteers. Each subject will be randomized for two subsequent doses in three cohorts.
- Conditions
- Aging, Mitochondrial Dysfunction, Muscle Function
- Trial name
- NCT02655393
- Testing
- Mitopure
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Amazentis SA