Clinical trials: Food Safety
Healthy
GLPG0259 Solid Formulation Bioavailability and Food Effect
The purpose of the study is to compare the pharmacokinetics of GLPG0259 as a solid dosage formulation (with and without food)and an oral solution, and to assess its safety and tolerability.
- Trial name
- NCT01024517
- Testing
- GLPG0259 solution, GLPG0259
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Peanut Allergy
Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy
This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen.
- Trial name
- NCT01451450
- Testing
- QGE031
- Sponsor
- Novartis Pharmaceuticals
HIV-1-infection, Hepatic Impairment
Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs
This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Class А and B), as well as to assess the…
- Trial name
- NCT03706898
- Testing
- Elpida®, Dolutegravir, Sofosbuvir
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Viriom
Healthy Participants
A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants.
The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixorafenib in healthy participants.
- Trial name
- NCT06385119
- Testing
- Plixorafenib, Cobicistat
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Fore Biotherapeutics
Healthy
To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers
This study aims to evaluate the effect of food on the pharmacokinetics and safety of DWP16001 after oral administration.
- Trial name
- NCT05797922
- Testing
- DWP16001
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy Subjects, Obesity
Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes
The phase 1 portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and multiple-ascending doses in healthy subjects.
- Conditions
- Healthy Subjects, Obesity, Type 2 Diabetes
- Trial name
- NCT05822544
- Testing
- TLC-6740 Oral Solution, TLC-6740 Tablet, Drug Metabolizing Enzyme
- Where
- 4 sites in New Zealand
- Volunteers
- 564 people, healthy volunteers welcome
- Sponsor
- OrsoBio, Inc
Gout; Hyperuricemia
Single Dose Study of SHR4640 in Healthy Subjects
The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.
- Trial name
- NCT02815839
- Testing
- SHR4640
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Weight Management
Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2…
- Trial name
- NCT06562907
- Testing
- GS-4571, Omeprazole
- Where
- 3 sites in United States
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Influenza
Evaluation the Safety and Tolerance of GP681 Tablets in Healthy Subjects
Influenza (influenza for short) is an acute respiratory infectious disease caused by influenza virus. The symptoms of the disease range from mild, moderate to severe, and severe cases require hospitalization and may die.
- Trial name
- NCT04729764
- Testing
- GP681 Tablet
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Type 2 Diabetes Mellitus (T2DM)
Clinical Study to Evaluate the Food Effect of CKD-383 0.5/25/1000mg 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 (NCT06695598)
- Testing
- CKD-383
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy Subjects
A Study of GSK1325760A in Healthy Japanese Subjects
To investigate the safety, tolerability, pharmacokinetics and the effect of food on pharmacokinetics after single oral administrations of GSK1325760A
- Trial name
- NCT00424034
- Testing
- GSK1325760A
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus (T2DM), Food Effect
Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes
The goal of this intervention study is to evaluate the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of MKP10241 in obese participants with and without T2DM in 3 parts.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Food Effect, Safety and Tolerability, Obesity
- Trial name
- NCT07098663
- Testing
- MKP10241
- Where
- Australia
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Mankind Pharma Limited
Healthy
This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the Blood
The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy male subjects following oral administration of multiple rising doses over 14 days (MRD part).
- Trial name
- NCT03100916
- Testing
- BI 690517, BI 690517 (Reference)
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hepatitis C
TD-6450 SAD and MAD in Healthy Subjects
This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.
- Trial name
- NCT02022306
- Testing
- TD-6450
- Where
- United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Healthy Volunteers, Hepatitis C Virus
Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin
This is an adaptive Phase I study to evaluate RO5024048 in the following groups: Healthy Volunteers (Part 1 - Single Ascending Dose Study) -Enrollment completed Hepatitis C virus (HCV) genotype 1 infected patients who have failed…
- Trial name
- R7128 (NCT00382798)
- Testing
- RO5024048
- Where
- 9 sites in United States, New Zealand and 1 more
- Volunteers
- 75 people
- Sponsor
- Pharmasset
Pain
Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)
This is a two-part randomized, double-blind, placebo-controlled study.
- Trial name
- NCT05484414
- Testing
- SRP-3D (diethylamide)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- South Rampart Pharma, Inc.
Type 2 Diabetes Mellitus (T2DM)
Clinical Study to Evaluate the Food Effect of CKD-378 in Healthy Volunteers
This study is a randomized, open-label, single dose, crossover study to evaluate the food effect of CKD-378 in healthy volunteers
- Trial name
- NCT06709807
- Testing
- CKD-378 25/1000mg
- Where
- South Korea
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy
Food Effect Study of CTP-543 in Healthy Volunteers
Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.
- Trial name
- NCT03880136
- Testing
- CTP-543
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Attention Deficit Hyperactivity Disorder (ADHD)
Vayarin® Medical Food Study for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.
- Trial name
- NCT02257216
- Testing
- Vayarin®
- Where
- 4 sites in United States
- Volunteers
- 171 people
- Sponsor
- Enzymotec
Healthy Volunteer
Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers
This is a Phase 1b, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and food effect of single oral doses of TRX-100 tablets and capsules in healthy adult volunteers.
- Trial name
- NCT07526506
- Testing
- TRX-100
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Traws Pharma, Inc.