RecruitingPhase 1ACTRN12618001509257

A Study of Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of VE-01902 in Healthy Volunteers

A multi-center, double-blinded, randomized, placebo-controlled, single ascending dose study with food effect crossover and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and hemostatic profile of VE-01902

Sponsor

VCR1

Enrollment

134 participants

Start Date

Jan 15, 2019

Study Type

Interventional

Conditions

Atrial Fibrillation

Summary

A multi-center, double-blinded, randomized, placebo-controlled, single ascending dose study and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and hemostatic profile of VE-01902. The single ascending dose phase will encompass a single bridging cohort across tablet strengths, and a food effect cohort.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This study is an early-phase clinical trial testing a new investigational compound called VE-01902 in healthy volunteers for the first time. The study is designed to understand how the body absorbs, processes, and eliminates the drug (pharmacokinetics), what effects it has on the body's clotting system (pharmacodynamics), and whether it is safe and tolerable. This type of 'first in human' testing is an essential step before any new drug can be studied in patients. Participants will receive either the drug or a placebo in a blinded fashion, starting at low doses and gradually increasing across different groups. The trial includes both single-dose testing (to understand immediate effects) and multiple-dose testing (to see what happens with repeated doses). Blood samples will be taken at regular intervals to measure drug levels and clotting parameters. To be eligible you need to be a healthy adult aged 18 to 55 with a BMI between 19 and 33 kg/m2, have no significant health conditions, and test negative for HIV, hepatitis B, and hepatitis C. Women must be postmenopausal or using reliable contraception, and men must use contraception during and after the study. People who smoke more than 10 cigarettes per week, drink heavily, or have taken any prescription medications recently are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Healthy volunteer study with single dose and multiple ascending doses: For the SAD, VE-01902 will be administered to fasted patients as an enterically coated oral tablet or as an oral suspension st

Healthy volunteer study with single dose and multiple ascending doses: For the SAD, VE-01902 will be administered to fasted patients as an enterically coated oral tablet or as an oral suspension starting at 45mg/kg/day for 1 day of dosing. There will be 6 cohorts, with an option to add a 7th if a certain PD threshold has not been met, and there were no serious safety signals. The second cohort will be used to investigate the differences between the different tablet strengths. Dosing levels will be adaptively decided after each dosing of a cohort via reviewing the PD and safety data by the safety review committee (SRC). There will be a maximum increase of 3x. Once a cohort hits a certain biologically relevant dose, a portion of subjects from a single cohort will be brought back for the same dose of drug, after a 9 day washout period. This dose will be administered after a high-fat breakfast to assess the effect of food on the drug. The ensuing SAD cohorts will be dosed in a fasted or fed state, depending on these results. The maximum dose will be decided by reviewing PD and safety data, passed down from the SRC. For the MAD, VE-01902 will be administered, to either fasted or fed patients depending on the food effect cohort, as an enterically coated oral tablet or as an oral suspension starting at a dose level decided from the SAD's available data, for 7 consecutive days of once-a-day dosing in the first MAD cohort. After the first cohort, the dose will be administered for 5 consecutive days of once-a-day dosing. There will be 4 cohorts, with an option to add a 5th if a certain PD threshold has not been met, and there were no serious safety signals. The maximum dose will be decided by reviewing PD and safety data, passed down from the safety review committee. Adherence will be monitored through visual confirmation of dosing.