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
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active…
- Trial name
- PEOPLE (NCT03013517)
- Testing
- Viaskin Peanut 250µg
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 300 people
- Sponsor
- DBV Technologies
Healthy
A Study of IBI3032 in Chinese Healthy Subjects
This is a randomized, double-blind, placebo-controlled Phase I clinical study evaluating the safety, tolerability, PK and food effect of a single dose of IBI3032 in healthy participants.
- Trial name
- NCT07134127
- Testing
- IBI3032
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)
Peanut Allergy
A Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine
The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal (ID) injection in adolescent participants with peanut allergy.
- Trial name
- NCT03755713
- Testing
- ASP0892
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral Azacitidine
The primary purpose of this study is to evaluate the pharmacokinetics of oral azacitidine when administered once daily as two 150-mg tablets, including the effect of food, and to evaluate the bioavailability of oral azacitidine…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- NCT01519011
- Testing
- oral azacitidine
- Where
- 8 sites in United States
- Volunteers
- 34 people
- Sponsor
- Celgene
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168
The primary objective of this clinical trial is to evaluate the effect of a high-fat, high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral administration of a single dose of 30 mg CCX168 to healthy…
- Trial name
- NCT05988021
- Testing
- CCX168
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Volunteers
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0211 in Healthy Adult Subjects Including a Food Effect Cohort
This first-in-human (FiH) study consists of 2 parts: single ascending dose (SAD) with evaluation of food effect (Part 1) and multiple ascending dose (MAD) (Part 2).
- Trial name
- NCT03682484
- Testing
- MA-0211
- Where
- United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the…
- Trial name
- NCT02044406
- Testing
- BI 1181181, BI 1181181, R, BI 1181181, T2
- Where
- Germany
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Dyslipidemia
Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519(CKD-519 FDI)
The purpose this study investigate the effect of food on the pharmacokinetics/pharmacodynamics and safety of CKD-519
- Trial name
- NCT02484482
- Testing
- CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
- Where
- South Korea
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Cow's Milk Protein Allergy (CMPA)
TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)
This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed formula in young children aged 1~3 years with diagnosed with or highly suspected CMPA in a real-world clinical practice…
- Trial name
- NCT07855796
- Testing
- Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Teyi Yinuo Health Technology Co., Ltd.
HIV Infections
VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI)
This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants.
- Trial name
- NCT06533280
- Testing
- Part A, C and D: VH3739937 500 mg, Part A: VH3739937 100 mg, Part B: Treatment A
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Ulcerative Colitis (UC)
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally in Healthy Adult Participants and Patients With Active Ulcerative Colitis
A study to investigate the safety, tolerability, and pharmacokinetics (PK) of ONO-6414 orally in healthy adult participants and in patients with active ulcerative colitis (UC).
- Trial name
- NCT07749768
- Testing
- ONO-6414
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Healthy Volunteers and Diabetes Participants
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
This is a Phase 1/2 randomized study of oral doses of PAL-119 in healthy volunteers and participants with diabetes.
- Trial name
- NCT07901595
- Testing
- PAL-119
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Paulex Bio Inc.
Healthy
A Study to Investigate the Safety, Tolerability, Food Effect, and Pharmacokinetics of JNJ-54416076 in Healthy Participants
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of JNJ-54416076 and any associated metabolite(s) (in Part 1) and safety, tolerability and PK of JNJ-54416076 when co administered with food…
- Trial name
- NCT02670395
- Testing
- JNJ-54416076
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Cow's Milk Protein Allergy (CMPA)
Safety and Efficacy Evaluation of an Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy (CMPA)
This is a prospective, multi-center, randomized, open-label, active-controlled, parallel-group, non-inferiority study. The goal of this clinical trial is to evaluate the clinical efficacy and safety of an extensively hydrolyzed…
- Trial name
- NCT07484035
- Testing
- Feihe Extensively Hydrolyzed Formula, Nestlé Extensively Hydrolyzed Formula
- Where
- 6 sites in China
- Volunteers
- 124 people
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Prader-Willi Syndrome, Obesity
Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome
The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adolescent and adult subjects with Prader-Willi Syndrome.
- Trial name
- bestPWS (NCT02179151)
- Testing
- ZGN-440 for Injectable Suspension
- Where
- 15 sites in United States
- Volunteers
- 108 people
- Sponsor
- Zafgen, Inc.
Healthy
Study of Danicopan in Participants of Japanese Descent
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.
- Trial name
- NCT04451434
- Testing
- Danicopan
- Where
- Australia
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hereditary Angioedema
A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers
A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers.
- Trial name
- NCT04349800
- Testing
- KVD900
- Where
- United Kingdom
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Healthy Adult Subjects
ONO-7746 Study in Healthy Adult Subject
The primary objective of this study is to evaluate the safety and tolerability of NON-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746 and…
- Trial name
- NCT01106664
- Testing
- ONO-7746
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Atrial Fibrillation
Study to Assess the Safety, Tolerability, Pharmacokinetic of Thrv-1268
This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD).
- Trial name
- NCT06507839
- Testing
- THRV-1268
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Thryv Therapeutics, Inc.