Clinical trials: Food Safety
Healthy
A First-in-Human Study to Assess Single and Multiple Doses of NXC736 in Healthy Participants
This is a randomized, double-blind, placebo- controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NXC736 after oral…
- Trial name
- NCT05079425
- Testing
- NXC736
- Where
- South Korea
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- NEXTGEN Bioscience
Healthy Volunteer
Single Ascending Dose, Multiple Ascending Dose, Food Effect Study
This is a 2-part study. Parts 1 and 2 will be a randomized, double-blind, placebo-controlled investigations of SAD (Part 1) and MAD (Part 2) of orally administered INV-101 in healthy adult subjects.
- Trial name
- NCT06938204
- Testing
- INV-101
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Innovo Therapeutics, Inc.
Healthy Volunteers
A Study to Evaluate the Effect of Food on Fixed-Dose Combination of MP-513 10 mg and Metformin XR 750 mg
The purpose of this study is to compare the safety and pharmacokinetic characteristics of fixed-dose combination of MP-513 10mg and metformin XR 750mg administered in a high fat fed state versus fasting state to healthy male…
- Trial name
- NCT03787043
- Testing
- FDC(MP-513 10mg/Metformin XR 750mg)
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Handok Inc.
Healthy
Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292
This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate the effect of food on the pharmacokinetics…
- Trial name
- NCT01692184
- Testing
- 50 mg AVL-292, 100 mg AVL-292, 200 mg AVL-292
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Celgene
Healthy
Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male Subjects
Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects
- Trial name
- NCT03123185
- Testing
- BI 705564 (Test), BI 705564 (Reference)
- Where
- Germany
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Infectious Disease
A Multiple Dose Study of the Safety, Tolerability and PK of CMX157 in Healthy Subjects
This is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
- Trial name
- NCT02585440
- Testing
- CMX157
- Where
- Thailand
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- ContraVir Pharmaceuticals, Inc.
Healthy
Food Effect Study of CTP-656 in Healthy Male Volunteers
Three way crossover study to assess the bioavailability of 656 under fed and fasted conditions.
- Trial name
- NCT02680249
- Testing
- CTP-656
- Where
- Australia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Appetite Depressant, Overweight
Safety, Tolerability, Kinetics and Efficacy Study of Hoodia Gordonii Purified Extract (PYM50717)
The objective of this clinical study was to assess the safety, tolerability, efficacy (effects on appetite scores, food intake) and plasma kinetics of Hoodia gordonii purified extract (H.g.PE), when consumed twice-daily for 2 or…
- Conditions
- Appetite Depressant, Overweight, Body Weight
- Trial name
- NCT01306422
- Testing
- Hoodia gordonii purified extract (H.g.PE)
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Unilever R&D
Healthy
A Study to Assess NEU-627 in Healthy Participants
Phase 1, randomized, double-blind, placebo-controlled study of NEU-627 designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect.
- Trial name
- NCT06900751
- Testing
- NEU-627
- Where
- New Zealand
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Neuron23 Inc.
Idiopathic Pulmonary Fibrosis
The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female Subjects
A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female…
- Trial name
- NCT03502902
- Testing
- HEC 68498
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Allergy, Peanut Allergy
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
- Trial name
- NCT07003919
- Testing
- DBV712 250 mcg
- Where
- 91 sites in United States, Australia and 6 more
- Volunteers
- 480 people
- Sponsor
- DBV Technologies
Healthy Adult Subjects
A Study of TTYP01 in Healthy Adult Subjects
This is integrated Phase 1, Single centre, Randomized study will be conducted in 3 parts, each with a specific primary objective: Part A: To characterise the safety and tolerability of TTYP01 in healthy adult subjects; Part B: To…
- Trial name
- NCT04370431
- Testing
- TTYP01 single ascending doses, TTYP01, 60 mg, TTYP01, 120 mg
- Where
- Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Shanghai Auzone Biological Technology Co., Ltd.
Type 2 Diabetes Mellitus
Placebo-Controlled Clinical Nutrition Study of the Safety and Metabolic Effects of Two Medical Foods in Type 2 Diabetes
This 16 week placebo-controlled study evaluates the safety and impact of two medical food study products, WBF10 and WBF11, consisting of commensal microbes.
- Trial name
- NCT03893422
- Testing
- WB-010, WB-011
- Where
- 5 sites in United States
- Volunteers
- 76 people
- Sponsor
- Pendulum Therapeutics
Cow's Milk Protein Sensitivity
Specific Oral Tolerance Induction in Children Allergic to Cow's Milk Proteins
Induction of oral tolerance in children allergic to cow's milk proteins is not risk-free. The analysis of factors that may influence the outcome is of utmost importance.
- Trial name
- NCT01641731
- Testing
- Cow's milk
- Where
- Spain
- Volunteers
- 55 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
Healthy
A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 474121, and Whether it Makes a Difference if BI 474121 is Taken as a Tablet or a Drink.
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 474121 in healthy male subjects following oral administration of single rising doses.
- Trial name
- NCT04194645
- Testing
- BI 474121 tablet, BI 474121 oral solution
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
Phase 1 Study of Epetraborole Tablets
This is a Phase 1b double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and food effect of epetraborole tablets administered to healthy adult subjects for up to 28 days.
- Trial name
- NCT04892641
- Testing
- Epetraborole
- Where
- Australia
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- AN2 Therapeutics, Inc
Anaphylaxis Food
FMXIN002 in Patients at Risk of Anaphylaxis
Study Objective To evaluate the efficacy of FMXIN002, a powder-based intranasal epinephrine spray, for treating anaphylaxis. Study Design Hypothesis: FMXIN002 will terminate anaphylactic reactions as effectively-or more…
- Trial name
- NCT07045701
- Testing
- Epinephrine 4mg nasal powder spray, Adrenalin 0.5mg Injectable Product
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- Nasus Pharma
Prader-Willi Syndrome, Hyperphagia
Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome
This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).
- Trial name
- ZEPHYR (NCT03790865)
- Testing
- Livoletide
- Where
- 37 sites in United States, Australia and 6 more
- Volunteers
- 158 people
- Sponsor
- Millendo Therapeutics SAS
IgE-Mediated Food Allergy, Peanut Allergy
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
The purpose of this Phase III study is to evaluate the clinical efficacy and safety of remibrutinib in participants with peanut, or cow's milk ("milk", cooked and uncooked) or hen's egg ("egg", cooked and uncooked) immunoglobulin…
- Conditions
- IgE-Mediated Food Allergy, Peanut Allergy, Cow Milk Allergy, Egg Allergy
- Trial name
- NCT07768371
- Testing
- Remibrutinib
- Where
- 18 sites in United States
- Volunteers
- 576 people
- Sponsor
- Novartis Pharmaceuticals
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