213 Clinical Trials for Various Conditions
Study to determine the relative bioavailability of BGB-43395 solid dispersion tablet compared to salt tablet in healthy adult participants in Part 1 and the effect of food on the selected BGB-43395 formulation solid dispersion tablet or salt tablet in healthy adult participants in Part 2.
This study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD), Part 2 will be a Multiple Ascending Dose (MAD), and Part 3 will be a selected SAD cohort in a fed state. Safety will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms, blood laboratory analyses and occurrence of adverse events (AE).
The purpose of this study is to evaluate the safety and tolerability, and determine the blood levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of ASN002. Healthy volunteers will be participants in the study.
TLL018 is developed for treatment of autoimmune and inflammatory diseases including rheumatoid arthritis. The purposes of this study are (1) determining if and at what doses TLL018 is safe and can be tolerated when administered to humans, (2) assessing what TLL018 does to the body and how the body responds to TLL018 when given as single and multiple doses, and (3) assessing potential food effect on TLL018.
This is a single-dose, open-label, randomized, three-way crossover study to assess the effect of food on the absorption and bioavailability of PBI-200.
This study will explore the potential effects of high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 when administered as a single oral dose of 200 mg in healthy adult participants.
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of E7386 following single dose administration with and without a meal.
This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the effect of up to three formulations on the relative bioavailability of GSK2248761 100mg administered with and without food. Part A will evaluate two new formulations compared to the current formulation. Part B will evaluate one additional formulation if the bioavailability of the two formulations in Part A do not meet pre-specified criteria. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-10 days after the last dose of study drug.
This is a randomized, double-blind, placebo-controlled Phase 1 study of HA115 capsules administered orally to healthy adult volunteers.
This Phase 1, single-dose study will be conducted in adult male and female subjects (N = 16) who are in general good health and selected for participation in the study according to the selection criteria. This study will assess the effect of food on the pharmacokinetics of belzutifan Tablets. The study will consist of two periods and will be conducted in a crossover fashion.
This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs). In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label manner; once in the fasted state and once in the fed state.
The objective of this single-dose, open-label, randomized, two-period, two-way crossover, food-effect study is to evaluate the effect of food on the rate of absorption and oral bioavailability of a test formulation of lofexidine 400 μg (2 x 200 μg tablet) manufactured by US WorldMeds, LLC.
This is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the effect of food on the PK of levoketoconazole.
This is an open-label, randomized, single-dose, 3-period crossover, Williams' design, food-interaction (fasted and fed arms) study conducted in healthy subjects.
This will be a randomized, single-dose, open-label, two-period crossover study in 16 healthy subjects. The study will consist of two phases: Pre-randomization and Randomization. The Pre-randomization phase will have two periods: Screening and Baseline. In the Randomization Phase, subjects will be randomized to one of two possible treatment sequences (fed/fasted and fasted/fed). In each period, subjects will receive a single capsule containing 10 mg lenvatinib either with or without a standard breakfast. There will be a 2-week washout between treatments.
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. Pharmacokinetics of these three tablets will be evaluated and the investigation tablet with the optimal PK profile will be progressed to Part 2. In Part 2 the investigational tablet selected from Part 1 will be coadministered with food alone, an H2 blocker alone, or an H2 blocker given in combination with ascorbic acid to evaluate the effect on GSK1322322 pharmacokinetics. Plasma GSK1322322 PK profile, safety, and tolerability will be assessed from each dose group.
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 profile and determine the safety and tolerability of each dose in healthy male volunteers. Part 2 is an open-label, randomized, 3-period, 3-way crossover study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state.
Vapendavir (VPV) is potent virostatic antiviral agent active against all known enterovirus species. VPV binds to the viral capsid, thereby inhibiting viral attachment to the target cell and, independently, preventing release of viral RNA (ribonucleic acid) into the cell. Alt VPV-101 is meant to investigate vapendavir in patients with chronic obstructive pulmonary disease (COPD) who develop a rhinoviral infection. This is a Phase 1, open-label, unblinded study. The primary objective of this study is to characterize single and multiple dose (plus a loading dose) plasma PK profiles of VPV in healthy participants (Group A) and participants with COPD (Group B). Group A is an open-label, 2-sequence, and up to a 3-period, cross-over study to assess the single-dose PK parameters and safety of VPV. Healthy participants may opt to participate in only the first 2 periods, all 3 periods or BID dosing, but it is preferred that participants complete all 3 periods. Group B is an open-label, multi-dose investigation of VPV PK parameters and safety in participants with COPD. Post-dose, follow up will continue for a minimum of 14 days and a maximum of 30 days, depending on which Group the participant is in and which periods said participant completes. There is a target for up to 24 adult participants comprised of healthy participants and participants with COPD.
This Phase I, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 3 weeks.
This study is an open-label, randomized, single dose, four period, balanced crossover study to assess in eligible healthy male or female subjects.
This study is a two-part study. Part one is designed to see how different formulations of GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in the body. Part two is designed to see how repeat dosing affects how GSK364735 is absorbed in the body.
The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.
This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.
This study will assess the pharmacokinetics of AZD5462 film-coated tablet formulation in healthy participants.
The primary purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of E2730 of multiple ascending oral doses in healthy adult participants and to assess the differences in PK, safety, and tolerability of E2730 between healthy Japanese and non-Japanese participants following multiple doses. This study will also determine the effect of food on PK of E2730.
The purpose of this study was to assess the safety, tolerability, and pharmacokinetic (PK) of TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally in healthy participants and participants with mild cognitive impairment (MCI) or mild Alzheimer disease (AD).
This will be a 2-part study. PART 1 is an open-label, randomized, food effect study of AG-120. Subjects will be enrolled to a fed/fasted or fasted/fed treatment sequence in a 2-period crossover design. PART 2 is an open-label study to determine the safety and PK parameters of a single 1000-mg oral dose of AG-120.
This Phase 1, single-dose study will be conducted in adult female subjects (N = 16) who are in general good health and selected for participation in the study according to the selection criteria. This study will assess the effect of food on the pharmacokinetics of PT2385 Tablets. The study will consist of two periods and will be conducted in a crossover fashion.
A Phase 1, Open-Label, Randomized, Single-Dose, Parallel-Group Study to Evaluate the Food Effect on the Pharmacokinetics of TP-05 under Fed and Fasted Conditions in Healthy Participants.
The purpose of the study is to provide safety, tolerability, pharmacokinetics and food effects data of a single 8 mg oral dose of EC5026 in healthy subjects.