Clinical trials: Effect of Food
Healthy
A Study of Baricitinib in Healthy Participants
The purposes of this study are to determine: If there are any differences in the amount of baricitinib in the blood/body when taken in two different forms.
- Trial name
- NCT03212638
- Testing
- Baricitinib suspension, Baricitinib tablet
- Where
- Singapore
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Neoplasm, Advanced or Metastatic
A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants
The purpose of this study is to evaluate the relative bioavailability of a new tablet formulation of TAK-117 (new clinical trial material [NTM]) compared to the TAK-117 Process B capsules (current clinical trial material [CTM])…
- Trial name
- NCT02625259
- Testing
- TAK-117, Lansoprazole
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Sarcoma
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms…
- Trial name
- NCT01896505
- Testing
- KCP-330
- Where
- 2 sites in United States, Canada
- Volunteers
- 54 people
- Sponsor
- Karyopharm Therapeutics Inc
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
Obesity; Overweight
Effect of GLP-1 Analogue ROSE-010 on Appetite in Overweight and Obese Subjects
The primary objective of this study is to assess the efficacy of ROSE-010 on food intake in female subjects with overweight and obesity.
- Trial name
- NCT06621017
- Testing
- ROSE-010 99 mcg, ROSE-010 150 mcg
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Rose Pharma Inc
Healthy Participants
A Study of Baricitinib in Healthy Japanese Participants
The purpose of this study is to understand the relationship of 3 different dosage forms of baricitinib. This study will also explore the effect of food on how the body absorbs baricitinib.
- Trial name
- NCT02263911
- Testing
- Baricitinib
- Where
- Japan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People
The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is safe and how it goes in and out of the body in healthy people. PF-07817883 is for the potential treatment of COVID-19.
- Trial name
- NCT05580003
- Testing
- PF-07817883, Midazolam, Moxifloxacin
- Where
- 2 sites in United States, Belgium
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence Study of Colchicine Tablets
This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with…
- Trial name
- NCT01021020
- Testing
- Colchicine, Colchicine/Probenecid
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Malignant Melanoma
A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma
This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E…
- Trial name
- NCT01264380
- Testing
- RO5185426
- Where
- 10 sites in United States
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Healthy
A Study in Healthy Men to Test if Taking Different Formulations of BI 1358894 With or Without Food Influences the Amount of BI 1358894 in the Blood
The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1358894 administered as tablet formulation 2 (TF2a, TF2b) under fasted conditions compared with the tablet formulation 1 (TF1)…
- Trial name
- NCT03892616
- Testing
- BI 1358894 (B), BI 1358894 (C), BI 1358894 (D)
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteer Study
Study Investigating the Safety, Tolerability, PK and Food Effect of BEN8744.
BEN8744 is an experimental new medicine for treating inflammatory bowel diseases such as Ulcerative Colitis. The study will test single and repeated oral doses of BEN8744 or placebo.
- Trial name
- NCT06118385
- Testing
- BEN8744
- Where
- United Kingdom
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- BenevolentAI Bio
Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use
Food and Insulin Effect on QT/QTC Interval of ECG
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or…
- Conditions
- Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval, Moxifloxacin ECG Profile in Fed and Fasted State
- Trial name
- C11035 (NCT01642485)
- Testing
- Moxifloxacin 400 mg fasted, FDA breakfast, Continental breakfast
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Richmond Pharmacology Limited
Autistic Disorder, Autism Spectrum Disorder
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants
This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD (Part 1) and MAD (Part 2)) and food effect (FE) of RO6953958 following oral…
- Conditions
- Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Mental Disorders
- Trial name
- NCT04475848
- Testing
- RO6953958, Midazolam
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Schizophrenia
Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.
- Trial name
- NCT06036108
- Testing
- OPC-34712FUM/ Brexpiprazole fumarate
- Where
- Japan
- Volunteers
- 59 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Healthy
A Study in Healthy Men to Compare Two Different Oral Formulations of BI 1810631 and to Test How Food or Rabeprazole Influence the Amount of BI 1810631 in the Blood
BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market.
- Trial name
- NCT05380947
- Testing
- BI 1810631 - trial formulation 1 (TF1), BI 1810631 - new formulation (NF), Rabeprazole sodium
- Where
- Germany
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study of LY2409021 Formulations and the Effect of Food
The purposes of this study are to compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or…
- Trial name
- NCT01354496
- Testing
- LY2409021 Reference Form, LY2409021 Test-Med Formulation (medium particle size), LY2409021 Test-High Formulation (high particle size)
- Where
- Singapore
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Participants
A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants.
The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixorafenib in healthy participants.
- Trial name
- NCT06385119
- Testing
- Plixorafenib, Cobicistat
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Fore Biotherapeutics
Hereditary Tyrosinemia, Type I
Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1)
The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone 10 mg Tablet, under fasting and fed conditions (food-effect).
- Trial name
- NCT02750332
- Testing
- Nitisinone
- Where
- South Africa
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Healthy Volunteers
A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants
This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative bioavailability of capsule and tablet formulations of RO7017773.
- Trial name
- NCT03847987
- Testing
- RO7017773 Phase I Capsule, RO7017773 Phase II Tablet Unflavored, RO7017773 Phase II Tablet Sweetened/Flavored
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hypertension
A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet
This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of single oral dose of TAK-536TCH final formulation tablet in healthy adult male participants.
- Trial name
- NCT02348658
- Testing
- TAK-536TCH
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda