Clinical trials: Food Labeling
Diabetes Mellitus
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252
The purpose of this study is to evaluate the safety, tolerability, and PK of single oral doses of JTT-252 and the effect of food on the PK of JTT-252 in healthy subjects, and to evaluate the safety, tolerability, PK and PD of…
- Trial name
- NCT02120976
- Testing
- JTT-252
- Where
- 2 sites in United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Shionogi Inc.
Healthy
Food Effect Study of VHX-896 in Healthy Volunteers
A single center, two-period, randomized study to evaluate the food effect of VHX-896 tablets in healthy volunteers
- Trial name
- NCT06803290
- Testing
- VHX-896
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Healthy Volunteers
Study to Compare the Pharmacokinetics, Safety and Tolerability of the Pediatric and Adult Branaplam Formulation in Healthy Adults and the Effect of Food on the Latter.
This is a Phase 1 study designed to assess the relative bioavailability (BA), safety and tolerability and PK of the pediatric and adult formulations of branaplam.
- Trial name
- NCT05330286
- Testing
- LMI070
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy
Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers
Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)
- Trial name
- NCT01541488
- Testing
- BI 1021958
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Non Small Cell Lung Cancer
TGRX-326 Pharmacokinetic Food Effect Bioavailability Study
A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326, a drug indicated for non-small cell lung cancer…
- Trial name
- NCT06304805
- Testing
- cycle 1: treatment drug, cycle 1: reference drug, cycle 1: fasted
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shenzhen TargetRx Co., Ltd.
Menopause, Menopause Hot Flashes
Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women
This proof-of-concept, open-label, single-arm study is designed to evaluate the effects of daily consumption of Haelan 951, a fermented soy conventional food product, on self-reported menopausal vasomotor symptoms, sleep quality…
- Conditions
- Menopause, Menopause Hot Flashes, Menopause Related Conditions
- Trial name
- H951-MENO (NCT07751029)
- Testing
- Haelan 951
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Spectrum Clinical Research, LLC
Healthy Subjects
A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam
The main objectives of this phase 1 trial are to evaluate the effect of food on the pharmacokinetics (i.e. how long and how much a compound is present in the blood) of ACT-541468 and to evaluate whether ACT-541468 can affect the…
- Trial name
- NCT03017495
- Testing
- Midazolam, ACT-541468
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Healthy Volunteers
A Study to Investigate the Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax in Healthy Adults
The purpose of this study is to evaluate whether blood levels of sonrotoclax after administration of a tablet for oral suspension are similar to those observed with the current sonrotoclax tablet.
- Trial name
- NCT07628881
- Testing
- Sonrotoclax Tablet for Oral Suspension, Sonrotoclax Tablet
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- BeOne Medicines
Peanut Allergy
Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents
To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17…
- Trial name
- NCT03703791
- Testing
- AR101
- Where
- 11 sites in Spain
- Volunteers
- 1 people
- Sponsor
- Aimmune Therapeutics, Inc.
Healthy
A Study of Food Effect and Esomeprazole on LY4064809 in Healthy Adult Participants
The purpose of this study is to evaluate the safety and effect of food on LY4064809 and the safety and effect of stomach changes by a proton pump inhibitor (PPI) esomeprazole, under fasted conditions in healthy adult…
- Trial name
- NCT06991179
- Testing
- LY4064809
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
Dermatitis, Atopic
A Pharmacokinetic Study to Evaluate BBI-5000 Capsules and Food Effect in Healthy Adult Subjects
To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of BBI-5000 capsules in healthy adult subjects.
- Trial name
- NCT02590289
- Testing
- BBI-5000
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fresh Tracks Therapeutics, Inc.
Healthy Volunteers
Bioavailability of Enasidenib (CC-90007) Sprinkle Formulation Relative to the Reference Tablet Formulation and Effect of Food on the Pharmacokinetics of Sprinkle Formulation in Healthy Adults
This is an open-label, single-center, randomized, three-period, two-sequence crossover study in healthy adult subjects to occur at one site in the United States.
- Trial name
- NCT04310527
- Testing
- Enasidenib
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Celgene
Cystic Fibrosis
A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor
This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.
- Trial name
- NCT01899105
- Testing
- lumacaftor, ivacaftor
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy
A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants
The purpose of this study is to compare the rate and extent of absorption (relative bioavailability) of seltorexant Phase 3 test formulation(s) relative to a reference Phase 2b tablet formulation dosed in the evening under fasted…
- Trial name
- NCT03682380
- Testing
- Seltorexant High Dose, Seltorexant Low Dose
- Where
- United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Major Depressive Disorder
A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder
The purpose of this study is to determine the safety and tolerability of ascending oral doses of CYB003 in healthy participants with and without major depressive disorder (MDD).
- Trial name
- NCT05385783
- Testing
- CYB003, Psychotherapy, Psychological Support
- Where
- 3 sites in United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Cybin IRL Limited
Advanced Solid Tumors, Solid Tumors
A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors
This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft…
- Conditions
- Advanced Solid Tumors, Solid Tumors, Ovarian Cancer, Breast Cancer
- Trial name
- NCT04672460
- Testing
- TALZENNA capsule, Talazoparib soft gel capsule
- Where
- 31 sites in United States, Australia
- Volunteers
- 73 people
- Sponsor
- Pfizer
Healthy Subjects
Study to Evaluate the Pharmacokinetics of Oral Sparsentan Suspension
This single-center, open-label, randomized, single and multiple-dose, 3-way sequential study at 3 dose levels will be performed in healthy subjects. Subjects will be randomized to 1 of the 3 dose levels.
- Trial name
- NCT05562362
- Testing
- RE-021, sparsentan
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Travere Therapeutics, Inc.
Healthy Volunteer
Study Evaluating the Effects of Food, Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-122
This is a phase 1 open-label 4-part study to evaluate the effect of food, cytochrome P450 inhibition and induction on the pharmacokinetics of CC 122 in healthy adult subjects. Approximately 81 subjects will be enrolled.
- Trial name
- NCT03340662
- Testing
- CC-122, Itraconazole, Fluvoxamine
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Celgene
Healthy
Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability
This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.
- Trial name
- NCT02581553
- Testing
- lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, allopurinol 300 mg
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
Fibrodysplasia Ossificans Progressiva
Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects
Study to evaluate the effect of food and the effect of swallowing capsule whole versus sprinkling on apple sauce on the pharmacokinetics (PK)/bioavailability of palovarotene, and evaluate the effect of palovarotene on the PK of…
- Trial name
- NCT04829773
- Testing
- Palovarotene, midazolam
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Clementia Pharmaceuticals Inc.