Clinical trials: Food Safety
Schizophrenia or Schizoaffective Disorder
Single-ascending Dose Study With a Food-Effect Cohort to Evaluate AMG 581
The purpose of this study is to find out the time it takes to absorb, distribute, breakdown and remove the drug from the body, safety and tolerability of AMG 581 in healthy participants and subjects with schizophrenia.
- Trial name
- FIH (NCT02567370)
- Testing
- AMG 581
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Volunteers
Evaluation of Oral PF614 Relative to OxyContin (PF614-102)
This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B).
- Trial name
- NCT05043766
- Testing
- PF614, Naltrexone Hydrochloride, OxyContin
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Ensysce Biosciences
Contrast-induced Nephropathy Following Percutaneous Intervention (CIN)
Efficacy and Safety of a Beet-Derived Inorganic Nitrate-Based Food Product for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Percutaneous Coronary Intervention
Contrast-induced nephropathy (CIN) is a common complication in high-risk patients undergoing percutaneous coronary intervention (PCI) due to exposure to iodinated contrast agents.
- Trial name
- BEET-CIN (NCT06984406)
- Testing
- Beet-Derived Inorganic Nitrate-Based Food Product
- Where
- Russia
- Volunteers
- 88 people
- Sponsor
- National Medical Research Center for Therapy and Preventive Medicine
Inflammatory Bowel Disease
A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of HRS-7085 Tablets in Healthy Subjects, With Assessment of Food Effects
This is a multicenter, randomized, double-blind, placebo-parallel-controlled, Phase I clinical trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of HRS-7085…
- Trial name
- NCT06175949
- Testing
- HRS-7085 Tablets, HRS-7085 simulant
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Infections, Bacterial
Relative Bioavailability, Safety, Tolerability, Pharmacokinetics (PK) and Food Effect Study of GSK2140944 in Healthy Subjects
This study will be conducted in three parts (Part 1, Part 2 and Part 3). Part 1 of this study will evaluate the relative bioavailability of a single dose of GSK2140944 tablet formulation compared to the reference capsule…
- Trial name
- NCT02045849
- Testing
- GSK2140944 capsule, GSK2140944 tablet, Itraconazole capsule
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study in Healthy Men to Find Out How Different Doses of BI 3009947 Are Tolerated and How Different Formulations or Food Influence How BI 3009947 is Taken up Into the Blood
Single-rising dose (SRD) part: The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3009947 in healthy participants following oral administration of single…
- Trial name
- NCT07250048
- Testing
- BI 3009947 (Formulation A), BI 3009947 (Formulation B)
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
HIV Infections
A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants
This is an open-label, single-dose, four-period, four sequential, and crossover study conducted to assess the relative bioavailability of GSK3640254 mesylate tablets and GSK3640254 mesylate capsules (in the presence of a moderate…
- Trial name
- NCT04128293
- Testing
- GSK3640254 Tablet, GSK3640254 Capsule
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Food Safety, Pregnancy Related
Evaluation of a Health Promotion Intervention on Food Safety in Women During Pregnancy
This is a comparative, observational study aiming to compare the diversity of the diet during pregnancy of women who have benefited from a health promotion intervention and who have not
- Conditions
- Food Safety, Pregnancy Related, Health Promotion
- Trial name
- NPTM2 (NCT06528535)
- Testing
- Health promotion intervention
- Where
- French Guiana
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier de Cayenne
Healthy
A Clinical Trial to Evaluate MK-4208/Embibatinib in Healthy Adult Participants (MK-4208-001/Embibatinib-1014)
The goal of the study is to learn what happens to different doses and forms of Embibatinib in a healthy person's body over time.
- Trial name
- NCT07838987
- Testing
- Embibatinib, Rabeprazole, Midazolam
- Where
- United States
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Bronchiectasis
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Food Effect of Single or Repeat Doses of GSK2793660 in Healthy Subjects
This study is the first administration of GSK2793660 to humans and will evaluate the safety, tolerability, PK and PD of single oral ascending doses of GSK2793660, and of repeat oral doses of GSK2793660 in healthy subjects.
- Trial name
- NCT02058407
- Testing
- GSK2793660 solution, GSK2793660 capsule
- Where
- United Kingdom
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Liver Disease (CLD)
A Clinical Trial to Assess the Pharmacokinetics, Safety, and Food Effect of AD-230 in Healthy Adults
A clinical trial to assess the pharmacokinetics, safety, and food effect of AD-230 in healthy adults
- Trial name
- NCT07618845
- Testing
- AD-230 (Fasted), AD-230 (Fed)
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Healthy
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects
This first-in-human study has three parts. In Parts A and B, the safety, tolerability, and pharmacokinetics (PK) will be evaluated following administration of single and multiple doses of KRP-A218, including food-effect.
- Trial name
- NCT04908800
- Testing
- KRP-A218, itraconazole
- Where
- United Kingdom
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Kyorin Pharmaceutical Co.,Ltd
Pharmacokinetics
Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants
This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total).
- Trial name
- NCT05527834
- Testing
- VNRX-7145, Ceftibuten
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
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
Healthy Volunteer
A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults
The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy adult volunteers.
- Trial name
- NCT05691699
- Testing
- ABBV-903, Itraconazole
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- AbbVie
Healthy
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid
This is a first in human (FIH), single-centre, double blind, randomised, cross-over, SAD followed by a MAD study of Inzomelid. The study is designed to evaluate the safety, tolerability, PK, PD, and food effect of Inzomelid in…
- Trial name
- NCT04015076
- Testing
- Inzomelid
- Where
- Australia
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Inflazome UK Ltd
Safety Issues, Tolerance
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers.
- Conditions
- Safety Issues, Tolerance, Pharmacokinetics, Food Effect
- Trial name
- NCT05217732
- Testing
- ZX-7101A
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Nanjing Zenshine Pharmaceuticals
Helicobacter Pylori Infection
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants
This was a single-center, randomized, double-blind, placebo-controlled phase 1 study to evaluate the safety, tolerability, pharmacokinetics of single ascending dose and the food effect on the pharmacokinetics of TNP-2198 capsules…
- Trial name
- NCT06081699
- Testing
- TNP-2198
- Where
- China
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics (Suzhou) Limited
Healthy
Study of Evaluation of Cavir Tab. 0.5mg With Food Effect on Pharmacokinetics and Safety
In this clinical trial, the investigator will clarify the difference in pharmacokinetics between the group single dose Cavir Tab. 0.5mg and single dose Cavir Tab. 0.5mg with high fatty meal for healthy adult volunteer.
- Trial name
- NCT02586363
- Testing
- Baraclude Tab. 0.5mg, fasting, Cavir Tab. 0.5mg, fasting, Cavir Tab. 0.5mg, high fatty meal
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Seoul St. Mary's Hospital
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants.
- Trial name
- NCT03918967
- Testing
- CT-G11, CT-G20
- Where
- South Korea
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Celltrion