Clinical trials: Food-drug Interaction
Food-drug Interaction
Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects.
to evaluate the comparative bioavailability of valproate from Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male volunteers under fasting and fed conditions.
- Trial name
- NCT06211283
- Testing
- Sodium valproate
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Desitin Arzneimittel GmbH
Healthy
Drug-drug Interaction (DDI) With a P-gp Inhibitor, Organic Anion Transporting Polypeptide OATP-inhibitor, Food Effect
The primary objective of this trial is to investigate the relative bioavailability of BI 685509 given alone under fasted conditions (Reference, R) compared to the intake after a high fat, high caloric breakfast (Test 1, T1), to…
- Trial name
- NCT03116893
- Testing
- BI 685509 After Standardised Breakfast, Itraconazole, Rifampin
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Fragile X Syndrome
CTH120 First-in-Human Study: Single and Multiple Ascending Doses and Potential Food Interaction
The purpose of this First-in-Human Phase I study is to investigate the safety, tolerability and pharmacokinetics of CTH120 in adult healthy volunteers.
- Trial name
- FIH-CTH120 (NCT06480968)
- Testing
- CTH120
- Where
- Spain
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Connecta Therapeutics, S.L.
Obesity
A Study to Assess S-309309 in Healthy and Obese Participants
The primary aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants.
- Trial name
- NCT05247970
- Testing
- S-309309, Midazolam
- Where
- United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Volunteer
Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults
The primary objective of Part 1 of the study is to evaluate the safety and tolerability of S-648414 after administration of a single oral dose of S-648414 in healthy adult study participants.
- Trial name
- NCT04147715
- Testing
- S-648414, Midazolam, Dolutegravir
- Where
- 2 sites in United States, Japan
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Shionogi
Healthy Participants
A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)
The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.
- Trial name
- NCT04468815
- Testing
- BMS-986278 Tablet, Esomeprazole, BMS-986278 suspension
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Volunteer
A Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers
This is a multiple part, multiple cohort study evaluating single and multiple ascending doses, relative bioavailability, food effect, and drug-drug interaction of NX-5948 in healthy volunteers.
- Trial name
- NCT06717269
- Testing
- NX-5948, Esomeprazole, Famotidine
- Where
- 2 sites in United States
- Volunteers
- 223 people, healthy volunteers welcome
- Sponsor
- Nurix Therapeutics, Inc.
Healthy Subjects
A Study to Evaluate if ID-085 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetic of single- and multiple-ascending doses of ID-085 in healthy subjects.
- Trial name
- NCT03372629
- Testing
- ID-085
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Clinical Trials, Phase I as Topic
First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080
This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled, randomized, single center design.
- Trial name
- NCT02817100
- Testing
- BAY1817080, Itraconazole
- Where
- Germany
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Bayer
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.
Healthy Female Adults
A Study of Navlimetostat (BMS-986504) Drug Interactions and Food Effect in Healthy Participants
The purpose of this study is to assess the food effect and drug interactions on drug levels of Navlimetostat in health adult female participants
- Trial name
- NCT07800897
- Testing
- Navlimetostat, Itraconazole, Rifampin
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Infections, Bacterial
Relative Bioavailability Study in Healthy Subjects
Part 1 of this study will assess the relative bioavailability of GSK1322322 administered as one of three investigational tablets compared to powder in a bottle formulation.
- Trial name
- PDF112034 (NCT00924911)
- Testing
- GSK1322322
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Pharmacokinetics of ASP8477, Pharmacodynamics of ASP8477
A Study to Assess the Effects of Single Ascending Doses (SAD) of ASP8477, the Effect That Food Has on the Drug, and the Interaction Between ASP8477 and Omeprazole in Healthy Postmenopausal Females and Healthy Young Vasectomized Males
This is a 4-part study. Part I assesses the safety and tolerability of single ascending doses of ASP8477 or a placebo under fasted conditions in postmenopausal subjects.
- Trial name
- NCT02220777
- Testing
- ASP8477, omeprazole
- Where
- 2 sites in Belgium, France
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Healthy Volunteers
A Food-Effect, Drug-Drug Interaction, and Pharmacokinetics Study of NX-5948 in Healthy Adult Subjects
This is a Phase 1, 2-part double-blinded (with respect to NX-5948/placebo), placebo-controlled study. Part 1 is a randomized, 3 period cross-over food-effect (FE) and drug-drug interaction (DDI) study.
- Trial name
- NCT06593457
- Testing
- IP
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Nurix Therapeutics, Inc.
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
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
Drug Interaction Study of MGL-3196 With Pioglitazone
The purpose of this study is to determine whether the single-dose pharmacokinetics (AUC) of pioglitazone are affected by chronic dosing with MGL-3196 100 mg/day in healthy subjects.
- Trial name
- NCT04671056
- Testing
- MGL-3196, Pioglitazone 15mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
HIV Infections
VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI)
This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants.
- Trial name
- NCT06533280
- Testing
- Part A, C and D: VH3739937 500 mg, Part A: VH3739937 100 mg, Part B: Treatment A
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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.