Clinical trials: Food Safety
Endometriosis
Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants
Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus.
- Trial name
- NCT05517746
- Testing
- BAY2395840 tablet, BAY2395840 oral solution
- Where
- Germany
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Bayer
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
Hepatic Insufficiency
Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency
This is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency.
- Trial name
- NCT04147936
- Testing
- AXA1665
- Where
- 11 sites in United States
- Volunteers
- 60 people
- Sponsor
- Axcella Health, Inc
Chronic Diseases
Precision Nutrition and Food Safety for Dietary Prevention of Chronic Disease Study
The associations between food nutrition and safety factors with the risk of chronic diseases are still unclear. This study is conducted in Jinhua, a city with a high prevalence of chronic diseases in China, to assess relations…
- Trial name
- PNFS (NCT05247632)
- Where
- 2 sites in China
- Volunteers
- 2,290 people
- Sponsor
- Zhejiang University
Mental Disorders
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
- Trial name
- NCT00449774
- Testing
- Lamotrigine IR tablets, Lamotrigine ODT tablets
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Subjects
Study Evaluating ISM5411 Administered Orally to Healthy Volunteers
The goal of this clinical trial is to learn about ISM5411 in healthy subjects. The primary objective is to evaluate the safety and tolerability of single and multiple oral doses of ISM5411 in healthy subjects.
- Trial name
- NCT06012578
- Testing
- ISM5411
- Where
- Australia
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- InSilico Medicine Hong Kong Limited
Irritable Bowel Syndrome Characterized by Constipation
Food Supplement Physiomanna® Baby in Pediatric Patients
The primary objective is to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation The secondary objective of the trial is to evaluate the adherence…
- Trial name
- NCT02732743
- Testing
- Physiomanna® Baby
- Where
- Romania
- Volunteers
- 45 people
- Sponsor
- Iuppa Industriale Srl
Healthy Subjects
Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects
This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study.
- Trial name
- NCT04488900
- Testing
- CKD-508 Capsule, CKD-508 Tablet
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Safety Issues, Tolerability
SB17170 Phase1 Trial in Healthy Volunteer
This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults.
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT05795192
- Testing
- SB17170
- Where
- South Korea
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- SPARK Biopharma
Healthy Volunteers
A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-631 in healthy adult volunteers.
- Trial name
- NCT07069036
- Testing
- SEP-631
- Where
- Australia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Septerna, Inc.
Essential Hypertension
Study of the Product QGC001 as a Single Dose and Multiple Doses Administered Orally to Healthy Adult Subjects
1QG2 is a Phase 1 study aiming to assess the safety and tolerability of ascending single/multiple oral doses (SAD \& MAD) in healthy young subjects, the preliminary food interaction and the effect of QGC001 on blood pressure and…
- Trial name
- NCT01900184
- Testing
- QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
- Where
- France
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Quantum Genomics SA
Healthy
Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects
A three (3) part study to evaluate the safety, tolerability and PK of RDN-929
- Trial name
- NCT03668314
- Testing
- RDN-929, RDN-929 TBD dose
- Where
- Netherlands
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Peanut Allergy
Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: To assess the efficacy of Viaskin Peanut after up to 36…
- Trial name
- OLFUS-VIPES (NCT01955109)
- Testing
- Viaskin Peanut 250 mcg
- Where
- 22 sites in United States, Canada and 2 more
- Volunteers
- 171 people
- Sponsor
- DBV Technologies
Drug Kinetics
Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics and Safety of Orally Administered Radotinib
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics and Safety of Orally Administered Radotinib in Healthy Adults
- Trial name
- NCT06461078
- Testing
- Radotinib HCl
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Il-Yang Pharm. Co., Ltd.
Sleep Initiation and Maintenance Disorders
Bioequivalence and Food Effect Study in Healthy Volunteers
The purpose of this study is to select the formulation with the optimal pharmacokinetic profile for an hypnotic drug to further develop in the market.
- Trial name
- NCT00495274
- Testing
- Formulation A, Formulation B, Formulation C
- Where
- Italy
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BVL-GSK098 in Healthy Volunteers
This is a phase I single-center, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics and food effect of BVL-GSK098 administered as single and multiple oral doses to…
- Trial name
- NCT04654143
- Where
- 2 sites in Spain
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- BioVersys AG
Tolerance
Tolerance and Safety of a Ketone-Promoting Food Ingredient
The objective of this study is to capture information on tolerance and safety of a ketone-promoting food ingredient in healthy adults.
- Trial name
- NCT04707989
- Testing
- Ketone- Promoting Food Ingredient #1, Ketone- Promoting Food Ingredient #2
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- BHB Therapeutics, Ireland LTD
Gout
D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting…
- Trial name
- NCT03291782
- Testing
- D-0120
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Peanut Allergy
Evaluating the Safety and Efficacy of Oral Encapsulated Fecal Microbiota Transplant in Peanut Allergic Patients
This is a Phase I trial to evaluate the safety and efficacy of oral encapsulated fecal microbiota transplantation (FMT) in the treatment of peanut allergy.
- Trial name
- NCT02960074
- Testing
- Fecal Microbiota Capsule
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Rima Rachid
Healthy
Safety, Tolerance, and Pharmacokinetics of Single Oral Doses of BI 201335 NA and Bioavailability in Healthy Male Subjects
The objective of this study was to investigate the safety, tolerability, and pharmacokinetics of BI 201335 NA following administration of single rising doses from 4 mg to 1200 mg.
- Trial name
- NCT02182323
- Testing
- BI 201335 NA
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim