Clinical trials: Food Safety
Healthy Subjects
A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.
- Trial name
- NCT05503693
- Testing
- AP303 50 μg, AP303 150 μg, AP303 300 μg
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Alebund Pty Ltd
Pharmacokinetics of New Curcumin Formulations, Safety of New Curcumin Formulations
Improved Oral Bioavailability of Curcumin Incorporated Into Micelles
Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous health-promoting activities. The oral bioavailability of curcumin is low due to its poor aqueous solubility, limited gastrointestinal…
- Trial name
- NCT01982734
- Testing
- curcumin
- Where
- Germany
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- University of Hohenheim
Healthy Volunteer, Pharmacokinetics of ASP1941
A Study to Assess Safety and Tolerability of ASP1941 After Single and Repeated Administration in Healthy Subjects
This study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 in healthy adult male subjects.
- Trial name
- NCT01121198
- Testing
- ASP1941
- Where
- Japan
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy
Oral Bioavailability,and Food Effect Study and Single Ascending Dose PK Study in Healthy Male Volunteers
This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study.
- Trial name
- NCT03372239
- Testing
- Indoximod base formulation, Indoximod HCL (salt) formulation
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- NewLink Genetics Corporation
Healthy
Safety, Tolerability, Biological Effects and Pharmacokinetics of BIIL 284 BS in Healthy Males
Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (=…
- Trial name
- NCT02265302
- Testing
- BIIL 284 oral solution, BIIL 284 wetability improved formulation (WIF) tablets
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Peanut Allergy
OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut
This is a phase 1, multi-center, randomized, double-blind, placebo-controlled study in adult participants with peanut allergy. Participants will be randomized in a 3:1 ratio to receive either an escalating dose of INT301 or…
- Trial name
- NCT04603300
- Testing
- INT301
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Intrommune Therapeutics
Healthy
A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects
A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects
- Trial name
- NCT04183686
- Testing
- ACT-1014-6470 (SAD), ACT-1014-6470 (MAD), 14C-ACT-1014-6470 microtracer
- Where
- Netherlands
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Celiac Disease, Celiac
A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).
- Conditions
- Celiac Disease, Celiac, Intestinal Disease, Malabsorption Syndromes
- Trial name
- NCT03644069
- Testing
- Nexvax2
- Where
- 41 sites in United States, Australia and 1 more
- Volunteers
- 146 people
- Sponsor
- ImmusanT, Inc.
Inflammatory Bowel Disease (IBD)
Phase I Study of QLS1510 Tablets in Healthy Participants
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QLS1510 in Healthy participants
- Trial name
- NCT07760077
- Testing
- QLS1510 Tablets
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
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.
NEC, Gastroschisis
Neokare Safety and Tolerability Assessment in Neonates With GI Problems
With an increasing body of evidence to support a causal link between drinking milk that contain cow's milk protein (CMP) and the development of gastrointestinal disturbance in infants, many clinicians avoid the use of CMP…
- Conditions
- NEC, Gastroschisis, Intestinal Perforation, Atresia, Intestinal
- Trial name
- NCT05293353
- Testing
- NeoKare Breast Milk Fortifier
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Nonalcoholic Steatohepatitis (NASH)
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 on an empty stomach (fasted condition) and…
- Trial name
- NCT03392779
- Testing
- ZSP1601 25 mg, ZSP1601 50 mg, ZSP1601 100 mg
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Mental Disorders
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
- Trial name
- NCT00449774
- Testing
- Lamotrigine IR tablets, Lamotrigine ODT tablets
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment
Phase 1a/1b BGB-290 for Advanced Solid Tumors.
The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2 (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and…
- Trial name
- NCT02361723
- Testing
- BGB-290
- Where
- 7 sites in Australia
- Volunteers
- 101 people
- Sponsor
- BeiGene
Healthy Volunteer
AZD8529 Single Ascending Dose Study
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single ascending doses
- Trial name
- SAD (NCT00755378)
- Testing
- AZD8529
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Obesity
A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect of HSG4112
1. Study Objective: The objective of this phase 1 clinical trial is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effect of HSG4112 after oral administration in healthy male…
- Trial name
- NCT04732988
- Testing
- HSG4112
- Where
- 2 sites in South Korea
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Glaceum
Healthy Volunteers
ANG-3070 in Healthy Adult Participants
This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants. This study is comprised of 12 cohorts.
- Trial name
- NCT04196179
- Testing
- ANG3070
- Where
- Australia
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Angion Biomedica Corp
Malaria
Safety and Pharmacokinetics Study of DM1157 to Treat Malaria
This is a phase 1 trial to evaluate the safety and pharmacokinetics of single and multiple ascending doses and effect of food on the pharmacokinetics of a novel antimalarial drug in healthy adults.
- Trial name
- NCT03490162
- Testing
- DM1157
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Endometriosis
Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants
Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus.
- Trial name
- NCT05517746
- Testing
- BAY2395840 tablet, BAY2395840 oral solution
- Where
- Germany
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Bayer
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