Clinical trials: Food-drug Interaction
Healthy Volunteers
First in Human Study of ORG-129 in Healthy Volunteers
The current study is performed to characterize the safety, tolerability and pharmacokinetics of ORG-129 after oral intake in healthy male and female volunteers after single ascending and multiple ascending doses.
- Trial name
- NCT04933565
- Testing
- ORG-129
- Where
- Spain
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Origo Biopharma
Healthy
A Study to Assess the Tolerability, Safety, Pharmacodynamics, and Pharmacokinetics of Ascending Single Doses (Including Food Interaction) and Ascending Multiple Doses of ACT-453859, and Multiple Doses of Setipiprant (ACT-129968)
This is a three-part study to assess the tolerability, safety, pharmacodynamics, and pharmacokinetics of ascending single doses (including food interaction) of ACT-453859 in healthy male subjects, of ascending multiple doses of…
- Trial name
- NCT02381496
- Testing
- ACT-453859 1 mg, ACT-453859 3 mg, ACT-453859 10 mg
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
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.
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 Subjects
A Study to Evaluate if AC-084 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects
The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and well-tolerated when orally administered at single- and multiple-ascending dose to healthy adults
- Trial name
- NCT02905253
- Testing
- AC-084
- Where
- United Kingdom
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Parkinson's Disease
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Profile of MT101-5 in Healthy Volunteers
The primary study objective is to establish the safety and tolerability of MT101-5 after a single and multiple dose administrations in healthy volunteers.
- Trial name
- NCT05844787
- Testing
- MT101-5
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mthera Pharma Co., Ltd.
Infections, Bacterial
Relative Bioavailability, Safety, Tolerability, Pharmacokinetics (PK) and Food Effect Study of GSK2140944 in Healthy Subjects
This study will be conducted in three parts (Part 1, Part 2 and Part 3). Part 1 of this study will evaluate the relative bioavailability of a single dose of GSK2140944 tablet formulation compared to the reference capsule…
- Trial name
- NCT02045849
- Testing
- GSK2140944 capsule, GSK2140944 tablet, Itraconazole capsule
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study of LY4268989 (MORF-057) in Healthy Participants
The purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese…
- Trial name
- NCT06964776
- Testing
- LY4268989, Midazolam
- Where
- United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
First-in-human: Single Ascending Dose, Food Effect, Drug-drug Interaction, Multiple Ascending Dose, Proof of Pharmacology
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of ASP6282 in healthy male and female subjects.
- Trial name
- NCT02420782
- Testing
- ASP6282, Itraconazole, Pilocarpine
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Healthy Participants
Study of BLU-808 in Healthy Adult Participants
This is a 3-part study. Parts 1 and 2 are randomized, double-blind, placebo-controlled investigations of single ascending doses (SAD) (Part 1) and multiple ascending doses (MAD) (Part 2) of orally administered BLU-808 in healthy…
- Trial name
- NCT06948032
- Testing
- BLU-808, Midazolam
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Blueprint Medicines Corporation
Food-drug Interaction
A Food-Effect Study of Hemay022 in Healthy Participants
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of Hemay022 following single dose administration with and without a meal.
- Trial name
- NCT04673474
- Testing
- Hemay022
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Tianjin Hemay Oncology Pharmaceutical Co., Ltd
Polycystic Ovary Syndrome
Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116
This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.
- Trial name
- NCT03119077
- Testing
- BAY1161116, Itraconazole
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
NSCLC
Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects
This study is divided into Part I and Part II. Part I is the food effect study. A total of 20 healthy subjects, regardless of gender, will be enrolled in a randomized, open-label, crossover design.
- Trial name
- NCT05902728
- Testing
- HLX208, Itraconazole 200 mg, Rifampicin
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Effect of Food, Pharmacokinetics
Food Interaction Study To Assess the Effect of Food on the Pharmacokinetics of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg
The purpose of the study is to investigate the effects of food, in comparison to fasting conditions, on the extent and rate of absorption of acetylsalicylic acid (ASA) and esomeprazole.
- Trial name
- NCT01163630
- Testing
- esomeprazole/ASA Fixed Dose Combination (FDC)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pharmacokinetics, Safety
JOTROL PK, Safety, and Food Effect Assessment
Type of Study: Single Ascending Doses (SAD) Study Objectives: To characterize the pharmacokinetic (PK) profile of JOTROL (resveratrol) following oral administration of SAD ranging from 200 mg up to a dose currently estimated at…
- Conditions
- Pharmacokinetics, Safety, Food-drug Interaction
- Trial name
- NCT04668274
- Testing
- 200 mg resveratrol as JOTROL, 500 mg resveratrol as JOTROL, 700 mg resveratrol as JOTROL
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Jupiter Orphan Therapeutics Inc.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
Single-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-281959 / ACT-246475 in Healthy Male Subjects
Study Part I is a single-ascending dose study. Healthy male subjects to be included in the study and randomized in 6 dose groups, Groups A-F (8 subjects per group).
- Trial name
- NCT01954615
- Testing
- 5 mg ACT-281959 prodrug formulation I (Group A), 20 mg ACT-281959 prodrug formulation I (Group B), ACT-281959 prodrug formulation I (Groups C to G doses to be defined)
- Where
- France
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Healthy Volunteer
A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults
The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy adult volunteers.
- Trial name
- NCT05691699
- Testing
- ABBV-903, Itraconazole
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- AbbVie
Parkinson's Disease
Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202
The purpose of this study is to investigate the safety and tolerability of single oral rising doses of BIA 3-202 up to 800 mg (proposed doses 10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg) in groups of 9 healthy male…
- Trial name
- NCT02763787
- Testing
- BIA 3-202
- Where
- United Kingdom
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
ADPKD (Autosomal Dominant Polycystic Kidney Disease)
A Phase 1 Study of Single and Multiple Ascending Doses of GV-100
This is a first-in-human, multi-part clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), food effect, and drug-drug interaction (DDI) potential of GV-100 following oral administration in healthy…
- Trial name
- NCT07788014
- Testing
- GV-100
- Where
- Australia
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Gilva Therapeutics Inc.
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