View clinical trials related to Healthy Volunteers.
Filter by:This open-label, radiolabeled, single 100-mg dose study in 6 healthy male volunteers has been designed to further the understanding of human metabolism of lorlatinib. A prior radiolabel study using [14C]lorlatinib (study B7461004) identified an unexpected major metabolite in plasma; a benzoic acid metabolite (M8) resulting from cleavage of the amide and aromatic ether bonds of lorlatinib, accounting for 21.0% of the circulating radioactivity. However, due to the position of the 14C radiolabel on the carbonyl carbon, the metabolic fate of the larger fragment of lorlatinib resulting from this cleavage, the pyrido-pyrazole substructure, could not be determined. In this current study, the radiolabel will be on the pyrazole ring allowing for monitoring the metabolic fate of the pyrido-pyrazole part of the lorlatinib molecule cleaved during the formation of the M8 metabolite. Since M8 will not be radiolabeled, its concentrations in plasma will be determined using a validated assay. The sample size of 6 was selected to ensure at least 4 fully evaluable subjects with completed collections of plasma, urine, and fecal samples. This is a standard sample size used for mass-balance/ADME studies which include assessment of metabolic profiling, and is not based on empirical data or hypothesis testing criteria. Metabolic profiling of radiolabeled components will be performed on pooled plasma samples as well as on cumulative urine and feces excreted until Day 14 postdose or until one of the following early release criteria is met: 1) recovery in excreta of at least 90% of administered radioactivity, or 2) less than 1% of administered radioactivity being recovered in excreta from two consecutive days (ie, total for urine + feces should be <1% on 2 consecutive days). Plasma concentrations of both lorlatinib and its unlabeled M8 metabolite will be analyzed using validated assays. Information from this study will complement the metabolic profiling results from study B7461004, will help guide in the assessment of potential drug-drug interactions (DDIs) and the need for other DDI studies with lorlatinib. Banked biospecimens will be collected for the purpose of conducting research. Collecting biospecimens for exploratory analyses makes it possible to better understand the investigational product's mechanism of action and to seek explanations for differences in, for example, exposure, tolerability, safety, and/or efficacy not anticipated prior to the beginning of the study.
The purpose of this study is to evaluate the safety and tolerability and evaluate pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly Japanese male and female subjects.
An open-label, single centre, nonrandomized clinical study in healthy volunteers, with intervention over a 13---week period. After written informed consent, subjects will undergo screening evaluations (Visit 1). One week after visit 1, subjects who meet the selection criteria will enter a run---in period of 8 weeks where participants will receive paracetamol 1g tablet and collect a blood sample at monthly intervals (visits 2, 3 and 4). A final visit for safety assessment will take place at week 13 (visit 5). Blood samples will be used to quantify P, PG e PS.
A Phase 1, First-in-human, Oral Single and Multiple Dose-Escalation, Randomized, Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate Safety, Tolerability, Dosing, and Pharmacodynamics
This study will compare nicotine delivery and product satisfaction in healthy subjects either using several different types of electronic cigarettes or smoking a conventional cigarette.
This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of [14C]-plazomicin in healthy, adult male subjects.
The purpose of this study is to evaluate the administration of single doses of 2-HOBA in humans, with an escalation of doses that begins with the calculated Maximum Recommended Starting Dose. This evaluation will assess tolerability to oral administration of 2-HOBA, obtain pharmacokinetic data, characterize the 2-HOBA metabolic pathways, and determine the relation of dose to prevention of formation of bi-functional electrophile adducts in blood. Characterization of the metabolic fate of 2-HOBA will be supported by investigations that evaluate metabolism in microsomes and cells.
Primary objective: To assess the safety and tolerability of single ascending intravenous (i.v.) doses, a single subcutaneous (s.c.) dose of caplacizumab (Part I), and multiple s.c. doses of caplacizumab (Part II) in Japanese subjects. Secondary objectives: - To compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles (total vWF:Ag concentration levels [vWF:Ag], coagulation factor VIII [FVIII:C], and ristocetin cofactor activity [RICO]) after single i.v. or s.c. administration of caplacizumab in Japanese and White subjects. - To evaluate the immunogenicity of caplacizumab (anti-drug antibodies [ADA]) in Japanese subjects.
This is a phase 1 randomized,double-blind,placebo-controlled study with single oral dose of globalagliatin hydrochloride (SY-004) administered to chinese healthy subjects to evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of globalagliatin hydrochloride (SY-004).
This is a partially double-blind study in healthy adult subjects, which will be conducted as a placebo- and active-controlled, single-dose, crossover study. Twenty-eight subjects will be enrolled to ensure 24 subjects on all study periods. All subjects will receive all 3 study treatments (GC4419, placebo and moxifloxacin) in randomized sequence. Cardiodynamic assessment using continuous ECG recordings (Holters) will be performed for approximately 26 hours on the day of dosing (Day 1) in each study period. ECGs will be extracted serially pre- and post-dose and predefined timepoints at which subjects will be supinely resting. Subjects will be supinely resting for at least 10 minutes prior to and 5 minutes after each nominal timepoint for ECG extraction. Blood draws for PK will be performed in all periods at the same timepoints and always after ECG extraction. Subjects will be domiciled in the clinic from noon/afternoon of the day before dosing (Day -1) until completion of safety procedures on Day 2 in each study period. All subjects (including subjects who terminate the study early) will return to the clinical research unit (CRU) 14 (± 1) days after the last administration of study treatment for follow-up procedures and to determine if any Adverse Event (AE) has occurred since the last study visit.