Clinical trials: Food Safety
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
A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated and Taken up by the Body With or Without Food
The main objectives of the single rising doses (SRD) trial part are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following administration of single rising doses.
- Trial name
- NCT04801693
- Testing
- BI 1819479
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Subjects
Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules
This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and…
- Trial name
- NCT06279533
- Testing
- LV232
- Where
- China
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Vigonvita Life Sciences
Healthy
Safety and Tolerability of Lu AG06474 in Healthy Young Men
The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.
- Trial name
- NCT05003687
- Testing
- Lu AG06474
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
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
HIV-1
PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir
The purpose of the study is to determine the safety, tolerability and plasma pharmacokinetics (pk) (i.e., the levels of TMC558445 circulating in your blood over time) of increasing single oral doses of TMC558445 and of multiple…
- Trial name
- NCT00838760
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants
The primary purpose of the study is to evaluate the safety and tolerability of EA1080 following single and multiple ascending oral doses in healthy Caucasian and Japanese male participants.
- Trial name
- NCT04223960
- Testing
- EA1080
- Where
- United Kingdom
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- EA Pharma Co., Ltd.
Type 2 Diabetes Mellitus
To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers
This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
- Trial name
- NCT06492655
- Testing
- CKD-383(Fed), CKD-383(Fasted)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Healthy
Bioavailability, Food Effect and Safety, Tolerability of a New Oral Suspension in Comparison to the Marketed Moxifloxacin Tablet in Healthy Adults
The purpose of this study is to describe the pharmacokinetics of a new oral liquid moxifloxacin formulation and the influence of concommitant food intake on the pharmacokinetics in healthy adults compared to the marketed oral…
- Trial name
- NCT01073891
- Testing
- Moxifloxacin (Avelox, BAY12-8039), Moxifloxacin (BAY12-8039)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Irritable Bowel Syndrome
Phase I Clinical Trial of DA-6886 in Healthy Male Subjects
DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety…
- Trial name
- NCT01633723
- Testing
- DA-6886
- Where
- South Korea
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy
Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy Subjects
The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy subjects.
- Trial name
- Japan SMAD (NCT01318655)
- Testing
- NKTR-118
- Where
- Japan
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Cardiovascular Diseases
Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Prevention of Cardiovascular Disease
Resveratrol can exhibit benefits against cardiovascular diseases (CVDs) although the cardioprotective role of resveratrol as part of the human diet is not yet clear.
- Trial name
- FUNGRAPE (NCT01449110)
- Testing
- Grape extract in primary prevention (PP), Grape extract in SP, Resveratrol-enriched grape extract in PP
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- National Research Council, Spain
Healthy Subjects
A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult…
- Trial name
- NCT02391623
- Testing
- PF-06427878
- Where
- Belgium
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteer
Study to Assess the Safety, Tolerability, PK, ECG Effects, Food Effect, and Drug-drug Interaction (DDI) of Hormonal Contraceptives of PTI-428 in Healthy Female Volunteers
This trial will consist of three parts: the first two parts will enroll healthy female volunteers into a single ascending dose (SAD) and multiple ascending dose (MAD) treatment groups.
- Trial name
- NCT02846142
- Testing
- PTI-428, ethinyl estradiol and levonorgestrel
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Proteostasis Therapeutics, Inc.
Food Allergy
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy.
- Trial name
- NCT06261554
- Testing
- Dietary Supplement: Low dose OIT
- Where
- Poland
- Volunteers
- 39 people
- Sponsor
- Medical University of Warsaw
Major Depressive Disorder
Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects
The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects
- Trial name
- SUVN-911 (NCT03551288)
- Testing
- SUVN-911
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Suven Life Sciences Limited
Healthy
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 764198
To investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of multiple rising doses per day over 14 days and to explore the pharmacokinetics (PK) of BI 764198 after single and…
- Trial name
- NCT04102462
- Testing
- BI 764198
- Where
- Germany
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Cell Carcinoma
A Post Marketing Surveillance As Required By Philippine Food And Drug Administration
This is a post marketing surveillance which determines the safety profile of the product to Filipinos. This is a FDA requirement for registration.
- Trial name
- NCT01781442
- Testing
- Temsirolimus
- Sponsor
- Pfizer
Diabetes Mellitus, Diabetes Mellitus, Type 2
Single Dose Study of PF-04991532 in Healthy Subjects
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK) and preliminary food effect of PF-04991532 following single escalating oral doses in healthy adult subjects.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
- Trial name
- NCT01102673
- Testing
- PF-04991532
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Nonalcoholic Steatohepatitis (NASH)
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor.
- Trial name
- NCT02654002
- Testing
- Cilofexor
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences