Clinical trials: Food Safety
Hepatitis C
Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects
This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a study of the food effect in…
- Trial name
- INH-189-006 (NCT01445795)
- Testing
- 200 mg INX-08189 Fasted, 100 mg INX-08189 QD, 100 mg INX-08189 with low-fat meal
- Where
- 2 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- Bristol-Myers Squibb
Healthy
A Bioavailability Study of MIV-711 Oral Formulations in Healthy Volunteers
This is a single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following Single Doses of MIV-711 Capsule and Tablet Formulations in…
- Trial name
- NCT03443453
- Testing
- MIV-711
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Medivir
Enteral Feeding
Nutritional Tolerance and Safety of a Tube Feeding Formula in Children
To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.
- Trial name
- NCT05838495
- Testing
- formulated liquid diet
- Where
- Canada
- Volunteers
- 27 people
- Sponsor
- Société des Produits Nestlé (SPN)
Plaque Psoriasis
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult…
- Trial name
- NCT07024602
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Ascletis Pharma (China) Co., Limited
Pharmacokinetics of ASP1707, Pharmacodynamics of ASP1707
A Study to Assess the Safety, Tolerability and Effects of Single and Multiple Ascending Doses of ASP1707 in Healthy Male and Pre-menopausal Female Subjects, Including a Comparison of the Effects Under Fasted and Fed Conditions in Healthy Young Male Subjects
This study consists of four parts: Part 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy young male subjects to evaluate the safety, tolerability pharmacokinetics (PK) and effect on…
- Trial name
- NCT02368912
- Testing
- ASP1707 single dose of dose levels 1 -7, ASP1707 single dose fasted, ASP1707 single dose fed
- Where
- France
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Healthy Participants
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants
This is a Phase 1, double-blind, sponsor-unblinded, randomized, placebo-controlled study designed to characterize the safety, tolerability, and PK of JZP047 in healthy participants following single-ascending doses of study…
- Trial name
- NCT07377539
- Testing
- JZP047
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Healthy
A Study Investigating the Safety, Absorption and Elimination of GLPG3312, a New Drug in the Treatment of Inflammatory Diseases
The purpose of this study is to investigate how safe 2 different formulations (immediate-release (IR) and modified-release (MR) tablets) of the new compound GLPG3312 are and how well they are tolerated when they are administered…
- Trial name
- NCT03800472
- Testing
- GLPG3312 IR, GLPG3312 MR, GLPG3312 FE MR
- Where
- Netherlands
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Food Borne Diseases
Knowledge,Attitude and Practice of Food Handleres About Food Safety
The heavy burden of food borne diseases causes substantial economic losses to individual , households, health systems and entire nations.
- Trial name
- NCT04314063
- Testing
- nasal swap
- Where
- Egypt
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Assiut University
Pain
A Single Dose Escalation Trial of HRS-2129 in Healthy Subjects
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics in healthy subjects, and to evaluate the food effect on pharmacokinetics of HRS-2129.
- Trial name
- NCT06619392
- Testing
- HRS-2129
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Healthy
HS-10542 Study in Healthy Participants
This is a randomized, double-blind, placebo-controlled, dose escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and the food effect on the pharmacokinetics of HS-10542 in healthy…
- Trial name
- NCT07040046
- Testing
- HS-10542
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy
A Phase I Study of IDP-73152 Mesylate in Health Male Volunteer
A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152 mesylate after oral administration in healthy…
- Trial name
- PDF inhibitor (NCT01904318)
- Testing
- IDP-73152 mesylate 40 mg, IDP-73152 mesylate 80 mg, IDP-73152 mesylate 160 mg
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Healthy
A Study to Assess the Tolerability, Safety, Pharmacodynamics, and Pharmacokinetics of Ascending Single Doses (Including Food Interaction) and Ascending Multiple Doses of ACT-453859, and Multiple Doses of Setipiprant (ACT-129968)
This is a three-part study to assess the tolerability, safety, pharmacodynamics, and pharmacokinetics of ascending single doses (including food interaction) of ACT-453859 in healthy male subjects, of ascending multiple doses of…
- Trial name
- NCT02381496
- Testing
- ACT-453859 1 mg, ACT-453859 3 mg, ACT-453859 10 mg
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Malaria
Safety and Pharmacokinetics Study of DM1157 to Treat Malaria
This is a phase 1 trial to evaluate the safety and pharmacokinetics of single and multiple ascending doses and effect of food on the pharmacokinetics of a novel antimalarial drug in healthy adults.
- Trial name
- NCT03490162
- Testing
- DM1157
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
A Pharmacokinetic Study of TP-05 in Healthy Subjects
A Phase 1, Randomized, Double-Blind, Single- and Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, Food-Effect and Pharmacokinetics of TP-05 in Healthy Subjects
- Trial name
- NCT05138796
- Testing
- TP-05 (lotilaner oral capsules)
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Tarsus Pharmaceuticals, Inc.
Type 2 Diabetes Mellitus
A Study to Evaluate the Food Effect on Drug Availability, Pharmacokinetic (PK) Properties, Safety and Tolerability of Two Different Dose Combination Therapy of Saxagliptin/Dapagliflozin/Metformin Extended-release (XR) Against Individual Component Co-administration.
A Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product (FCDP) of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxagliptin /10 mg Dapagliflozin /1000 mg Metformin XR…
- Trial name
- NCT03169959
- Testing
- 2.5 mg Saxagliptin tablet, 5 mg dapagliflozin / 1000 mg metformin XR tablet, Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Obesity
A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect of HSG4112
1. Study Objective: The objective of this phase 1 clinical trial is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effect of HSG4112 after oral administration in healthy male…
- Trial name
- NCT04732988
- Testing
- HSG4112
- Where
- 2 sites in South Korea
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Glaceum
Healthy Volunteers
A Study of E2086 in Healthy Adult Participants
The primary purpose of the study is to evaluate the safety and tolerability following multiple ascending doses of E2086 in healthy adult participants.
- Trial name
- NCT06481488
- Testing
- E2086
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy
Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects
The purpose of the study is to investigate the safety, pharmacokinetics and food effect of DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants.
- Trial name
- NCT02673593
- Testing
- DS102
- Where
- Ireland
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- DS Biopharma
Iron Deficiency
Safety and Tolerability of BioFe for Iron Deficiency Management
This study evaluates the safety, tolerability, and activity of BioFe in the dietary management of iron deficiency in adults.
- Trial name
- NCT03484026
- Testing
- BioFe
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Sidero Bioscience, LLC
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)