Clinical trials: Food Safety
Hepatitis C, Chronic
First in Human Study of ALS-002200; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered ALS-002200 in healthy volunteers (HV) and subjects with chronic hepatitis C (CHC)…
- Trial name
- NCT01590407
- Testing
- ALS-002200
- Where
- 4 sites in France, Moldova and 1 more
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma 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
Primary Liver Cancer
Effect of Food and Formulation on the Pharmacokinetics, Safety, and Tolerability of GNS561 After One Single Dose (50 and 200mg) in Healthy Volunteers
GNS561 is a drug used in preliminary phase 1b study for treatment of patients with primary and secondary liver cancer. The formulation used was oral capsule.The objective of this study in healthy volunteers is to compare…
- Trial name
- NCT05353894
- Testing
- GNS561 oral tablets and capsules
- Where
- France
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Genoscience Pharma
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)
Safety
Single Dose and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4
A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. Cohorts of healthy adults (female and male) will participate in: single dose escalation study of increasing doses of MRX-4…
- Trial name
- NCT03033342
- Testing
- Oral single doses of MRX-4, Oral multiple doses of MRX-4, MRX-4 co-administered with omeprazole
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- MicuRx
Chronic Kidney Disease
Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects
This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate…
- Trial name
- NCT05638126
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Infections, Bacterial
Single Dose Escalation First Time in Human PK Study
This is a first time in human (FTIH) study of single escalating doses of investigational study drug to investigate safety, tolerability, and pharmacokinetics in healthy subjects
- Trial name
- NCT00828867
- Testing
- 100 mg GSK investigational drug, 200 mg GSK investigational drug, 400 mg GSK investigational drug
- Where
- Australia
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Pulmonary Hypertension
Preliminary Human Trials of F230 Tablets
F230 is a new Class 1 chemical drug jointly developed by Beijing Contini Pharmaceutical Co., Ltd. for the treatment of pulmonary hypertension (Notification number: 2024LP01242, 2024LP01243).
- Trial name
- NCT06899815
- Testing
- F230 tablets
- Where
- China
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd.
Healthy Participants, IBD (Inflammatory Bowel Disease)
A Phase I Study of HW201877 in Healthy Subjects
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single…
- Trial name
- NCT07373457
- Testing
- HW201877 capsules
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Safety and Tolerability in Healthy Volunteers
Safety and Tolerability Evaluation of BP-LT
This study evaluates the safety and tolerability of the food ingredient BP-LT when added to a daily diet. BP-LT is a stable protein ingredient being functional in the gastrointestinal tract and without systemic absorption.
- Trial name
- NCT07819695
- Testing
- BP-LT
- Where
- Bangladesh
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bactolife A/S
Gout, Hyperuricemia
SAD,MAD and Food Effect Study of SAP-001 Tablets in Chinese Subjects
To evaluate the pharmacokinetics (PK) profile of single or multiple oral doses of SAP-001 tablets in healthy Chinese subjects and gout patients with hyperuricemia.
- Trial name
- NCT06678581
- Testing
- SAP-001
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shanton Pharma Co., Ltd.
Gastroesophageal Reflux
A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers
The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2 different formulations, assess the effect of food on the pharmacokinetics and assess safety of rabeprazole sodium in healthy volunteers.
- Trial name
- NCT01101646
- Testing
- rabeprazole sodium
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
Single Ascending Dose PK, Oral Bioavailability and Food Effect 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 a randomized single ascending dose study of indoximod salt formulation to characterize the PK…
- Trial name
- NLG2111 (NCT03852446)
- Testing
- Indoximod HCL (F2) tablets, Indoximod base formulation
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- NewLink Genetics Corporation
Safety, Tolerability, Pharmacokinetics of AEF0217
AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects.
This trial is divided in 3 parts: FIH-SAD (Single Ascending Doses), FIH-MAD (Multiple Ascending Doses) and FIH-FE (Food effects). FIH-SAD will start first.
- Trial name
- AEF0217-101 (NCT05170737)
- Testing
- AEF0217
- Where
- Spain
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Aelis Farma
Glycemic Index
Safety and Efficacy of a Single Dose of a Polyphenol-enriched Brown Seaweed Powder in Human
The primary endpoint of this trial will be to evaluate the safety of a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a test meal.
- Trial name
- ICAST (NCT00936754)
- Testing
- Brown seaweed powder
- Where
- Canada
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- innoVactiv Inc.
Healthy Adult Male and Female Volunteers
A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years
Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.
- Trial name
- NCT07413666
- Testing
- ORX489 Tablets
- Where
- United States
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Fungal Infection
Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally
This is a Phase l double-blind, placebo-controlled, randomized study to investigate the safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of APX001 administered intravenously and orally…
- Trial name
- NCT02957929
- Testing
- APX001 single IV dose, APX001 single oral dose 1, APX001 single oral dose 2
- Where
- 2 sites in Netherlands
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Healthy
A Food Effect Study of CT-L01 After Oral Administration in Healthy Volunteers
This is a phase 1, randomized, open-label, single-dose, crossover, single-center study to evaluate food effect on the pharmacokinetics and safety of CT-L01 after oral administration in healthy volunteers.
- Trial name
- NCT05364164
- Testing
- CT-L01 12.5/1,000 mg
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Celltrion
Respiratory Syncytial Virus Infections
Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers
This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.
- Trial name
- NCT01906164
- Testing
- ALS-008176
- Where
- France
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.