Clinical trials: Food Safety
Hutchinson-Gilford Progeria Syndrome, Werner Syndrome
Phase I Study of Progerinin in Healthy Volunteers
PRG-PRO-001 is a Phase I, Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose (SAD) Study including a food interaction study, followed by a Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability…
- Trial name
- NCT04512963
- Testing
- Progerinin
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- PRG Science & Technology Co., Ltd.
Type 2 Diabetes Mellitus
A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379
This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers
- Trial name
- NCT06204107
- Testing
- CKD-379(Empagliflozin+sitagliptin+metformin) Test drug, CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
- Where
- South Korea
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
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
Healthy Subjects
A Single Ascending Dose, and Food Effect Study of ABBV-7828 in Healthy Adults
This study is to evaluate safety, tolerability, pharmacokinetics and effect of food on ABBV-7828 compared to placebo in healthy adult participants.
- Trial name
- NCT07856706
- Testing
- ABBV-7828
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AbbVie
Healthy Volunteers
Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy Participants
The purpose of this study is to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple doses, to assess food and pH effects on the relative bioavailability of BMS-986533, and…
- Trial name
- NCT07629999
- Testing
- BMS-986533, Famotidine, Dabigatran Etexilate
- Where
- United States
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Non-Alcoholic Fatty Liver Disease, Liver Fibrosis
Study in Healthy Adults Evaluating PF-07202954
The study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).
- Trial name
- NCT04857437
- Testing
- PF-07202954 Repeat Dose, PF-07202954 Single Dose
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Non-alcoholic Fatty Liver Disease
A Clinical Trial of XZP-6019 Tablets in Healthy Subjects
This study will consist of 3 parts: Part A - Single Ascending Dose (SAD) phase, Part B - Food Effect (FE) phase, and Part C - multiple ascending dose (MAD) phase.
- Trial name
- NCT05063968
- Testing
- XZP-6019 tablet
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Solid Tumors
Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors
The primary objective of this study is: Determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of BAY 1436032 in patients with isocitrate dehydrogenase-1 (IDH1)-R132X-mutant advanced…
- Trial name
- NCT02746081
- Testing
- BAY1436032
- Where
- 13 sites in United States, Denmark and 2 more
- Volunteers
- 81 people
- Sponsor
- Bayer
Healthy Participants, Alzheimer Disease
A Phase 1 Study to Assess the Safety and Effects of Single and Multiple Doses of KS101 in Healthy Volunteers
This study is the first clinical trial involving study drug KS101. The goal of this clinical trial is to investigate whether KS101 is safe, whether it causes side effects, and how KS101 is broken down in the body, in healthy…
- Conditions
- Healthy Participants, Alzheimer Disease, Chronic Kidney Disease
- Trial name
- NCT07143331
- Testing
- Part 1 KS101, Part 2 with Food, Part 2 without food
- Where
- Australia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Klotho Sciences Australia Pty Ltd.
Pulmonary Disease, Chronic Obstructive
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of GSK2256294 in Healthy Young Males and Elderly Subjects
This study will investigate the safety and pharmacokinetics (PK) of a single dose of GSK2256294 in healthy young and elderly subjects to explore the effects of food, gender and age on drug exposure.
- Trial name
- NCT02006537
- Testing
- GSK2256294
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Telogen Effluvium
Clinical Evaluation of a Nutraceutical Supplement (Olistic Women) for Hair Growth and Hair Loss in Human Volunteers
Hair loss is a multifactorial and complex condition influenced by factors such as hormonal changes, vitamin and mineral deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress.
- Trial name
- NCT07111312
- Testing
- Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.
- Where
- 2 sites in Spain
- Volunteers
- 106 people
- Sponsor
- Olistic Research Labs S.L.
Pain
A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects
This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HRS-6257 in healthy…
- Trial name
- NCT07301333
- Testing
- HRS-6257
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Dyslipidemia, Healthy Volunteers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia.
- Trial name
- NCT01487460
- Testing
- TAP311
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Food Allergy, Anaphylaxis
PK/PD Study of IN-001 Sublingual Spray in Healthy Adults
This is an open-label, three-part study to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine administered as a single dose of L-dipivefrin (IN-001) sublingual spray or drop in healthy adults.
- Conditions
- Food Allergy, Anaphylaxis, Food Hypersensitivity, Food Allergy Peanut
- Trial name
- NCT07210320
- Testing
- Epinephrine Auto-Injector 0.3 mg/0.3 mL, Epinephrine 0.3 mg intramuscular manual injection via a syringe and needle, IN-001 9.06 mg Sublingual Spray
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Insignis Therapeutics, Inc.
Healthy
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ACT-1004-1239 in Healthy Male Subjects
This Phase 1 study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of ACT-1004-1239 in healthy subjects.
- Trial name
- NCT03869320
- Testing
- ACT-1004-1239, ACT-1004-1239 (Food-effect subpart)
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Healthy Participants, Healthy Subjects
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases
This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different…
- Conditions
- Healthy Participants, Healthy Subjects, Healthy Volunteers, Autoimmune Diseases
- Trial name
- NCT06342713
- Testing
- BGB-45035
- Where
- 13 sites in Australia, China and 1 more
- Volunteers
- 203 people, healthy volunteers welcome
- Sponsor
- BeiGene
Iron Deficiency
Safety and Tolerability of BioFe for Iron Deficiency Management
This study evaluates the safety, tolerability, and activity of BioFe in the dietary management of iron deficiency in adults.
- Trial name
- NCT03484026
- Testing
- BioFe
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Sidero Bioscience, LLC
Peanut Allergy
HAL-MPE1 Safety and Tolerability Study
The aim of this study is to confirm safety and tolerability of incremental doses of HAL-MPE1 subcutaneous immunotherapy (SCIT) in peanut allergic adults, and subsequently assess the safety and tolerability in adolescents and…
- Trial name
- NCT02991885
- Testing
- HAL-MPE1
- Where
- 7 sites in United States, Canada
- Volunteers
- 42 people
- Sponsor
- HAL Allergy
Healthy Volunteer
Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults
The purpose of the study is to evaluate the effects of a high fat meal on the pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.
- Trial name
- NCT01634178
- Testing
- Apremilast
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy
A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878
Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple ascending dose trial in healthy younger and elderly adult subjects, with an open-label, randomised, crossover arms to assess the effect of…
- Trial name
- NCT03244228
- Testing
- HTL0016878
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited