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ORG-129

A groundbreaking clinical trial is currently underway to evaluate the investigational drug ORG-129 in healthy volunteers. This “First in Human” study aims to assess how safe and well-tolerated ORG-129 is when taken orally, while also examining how the drug moves through the body. The research includes both single and multiple dose administration to understand the drug’s behavior and effects in the human body. This initial testing in healthy individuals represents a crucial first step in the drug development process, providing valuable information that may guide future studies of ORG-129 in patient populations.

Table of Contents

What is ORG-129?

ORG-129 is an investigational medication currently in early-stage clinical testing. It is being studied as an oral medication in capsule form. As this drug is still in the initial phase of human testing, the specific conditions it may eventually treat are not yet disclosed in the available clinical trial information. The drug is currently being evaluated in healthy volunteers to establish its basic safety profile before moving to testing in patients with specific medical conditions.[1]

Clinical Testing Status

ORG-129 is currently in what’s called a “First in Human” clinical trial. This means it’s the very first time the drug is being tested in people after completing necessary laboratory and animal studies. The study is specifically designed to test the drug in healthy volunteers (people without medical conditions) to understand how the body processes the drug and to identify any potential safety concerns before testing it in patients with specific diseases.[1]

How ORG-129 is Administered

ORG-129 is being developed as an oral medication in capsule form. This means that if eventually approved, patients would take the medication by mouth. The current study is evaluating different dosing schedules, including single doses and multiple doses over several days.[1]

Study Design Details

The clinical trial for ORG-129 has several components designed to thoroughly evaluate how the drug behaves in the human body:

  • Single Ascending Dose (SAD) – Participants receive a single dose of the medication, with different groups receiving progressively higher doses to find the safe dose range. This helps researchers understand how the body handles a single dose of the medication.[1]
  • Multiple Ascending Dose (MAD) – Participants receive multiple doses of the medication over several days, again with different groups receiving progressively higher doses. This helps researchers understand how the body handles repeated exposure to the medication.[1]
  • Food Interaction Study – This part of the study examines whether taking the medication with food affects how the body absorbs and processes the drug.[1]
  • Pharmacokinetic/Pharmacodynamic (PK/PD) Evaluation – This detailed analysis measures how the drug moves through the body (pharmacokinetics) and what effects it has (pharmacodynamics).[1]

The study includes both the actual medication (ORG-129) and a placebo (an identical-looking capsule with no active medication). This design helps researchers determine which effects are actually caused by the medication versus effects that might occur due to other factors.[1]

Safety and Side Effects

A primary goal of this early-stage clinical trial is to assess the safety and tolerability of ORG-129. Researchers are carefully monitoring:

  • Treatment emergent adverse events – Any health problems that develop after participants take the medication. These are tracked for their number, severity, and type.[1]

For the single dose portion of the study, safety monitoring continues for 8 days after taking the medication. For the multiple dose portion, monitoring continues for 12 days. This extended monitoring helps researchers identify both immediate and delayed side effects.[1]

Since this is a very early stage study, comprehensive information about side effects is not yet available. Establishing this safety profile is actually one of the main purposes of the current trial.[1]

Understanding Pharmacokinetics of ORG-129

A significant portion of this clinical trial focuses on understanding how ORG-129 behaves in the human body, which is called pharmacokinetics. Several important measurements are being taken:

  • Area under the curve (AUC) – This measures the total exposure to the drug over time. It helps determine how much of the drug reaches the bloodstream.[1]
  • Maximum concentration (Cmax) – This is the highest level of the drug observed in the blood, indicating how intensely the body is exposed to the drug.[1]
  • Time to maximum concentration (Tmax) – This shows how quickly the drug is absorbed and reaches its highest level in the bloodstream.[1]
  • Oral clearance (CL/F) – This measures how quickly the body removes the drug from the bloodstream.[1]
  • Volume of distribution (Vz/F) – This indicates how widely the drug spreads throughout the body’s tissues.[1]
  • Elimination rate (Kel) – This shows how rapidly the drug is eliminated from the body.[1]
  • Half-life (t 1/2) – This is the time it takes for the concentration of the drug in the body to be reduced by half, which helps determine how often a medication needs to be taken.[1]
  • Steady state concentration (Css) – This is the stable level of drug in the body after taking multiple doses over time.[1]

These measurements help researchers understand the appropriate dosing schedule for the medication – including how much to give and how often.[1]

Future Research and Development

As ORG-129 is still in the earliest phase of human testing, much more research will be needed before it could potentially become an approved medication. Future studies would likely include:

  • Phase 2 studies – Testing in patients with specific medical conditions to determine if the drug is effective
  • Phase 3 studies – Larger scale testing to confirm effectiveness and monitor side effects in more diverse populations
  • Regulatory review – Evaluation by health authorities like the FDA to determine if the benefits outweigh the risks

The current study will help determine if ORG-129 has appropriate safety characteristics to continue this development process. The study is also analyzing biomarkers, which are measurable indicators that might show how the drug is affecting the body at a molecular or cellular level.[1]

Study Aspect Details
Study Title First in Human Study of ORG-129 in Healthy Volunteers
Primary Objective To assess safety, tolerability, pharmacokinetics and bioavailability of ORG-129
Study Population Healthy male and female volunteers
Study Design Single ascending dose (SAD) and multiple ascending dose (MAD) study with food interaction assessment
Drug Administration ORG-129 oral capsules vs. placebo oral capsules
Study Duration SAD: 8 days; MAD: 12 days
Primary Outcomes Safety and tolerability measured by treatment emergent adverse events
Secondary Outcomes Comprehensive pharmacokinetic parameters (AUC, Cmax, Tmax, CL/F, Vz/F, Kel, t 1/2, Css)
Clinical Trial ID NCT04933565

FAQ

  • What is the purpose of this clinical trial with ORG-129? This clinical trial aims to characterize the safety, tolerability, and pharmacokinetics (how the drug moves through the body) of ORG-129 after oral intake in healthy male and female volunteers. The study evaluates both single ascending doses (SAD) and multiple ascending doses (MAD) to understand how the body handles the drug in different dosing scenarios.
  • Who can participate in this ORG-129 clinical trial? This study is specifically designed for healthy volunteers. The trial includes both male and female participants who meet the study's eligibility criteria. As a 'First in Human' study, it's important to test the drug in healthy individuals before moving to patient populations with specific conditions.
  • How is the ORG-129 clinical trial structured? The trial includes several different groups (cohorts): Single ascending dose cohorts (up to 4), Multiple ascending dose cohorts (up to 4), a Food interaction cohort to see how food affects the drug, and a Multiple dose PK/PD cohort to study both pharmacokinetics and pharmacodynamics. Some participants receive the actual ORG-129 oral capsules, while others receive placebo capsules for comparison.
  • What are the main outcomes being measured in the ORG-129 trial? The primary outcomes focus on safety and tolerability, measured by tracking the number, severity, and types of side effects that occur. Secondary outcomes examine pharmacokinetic parameters – essentially how the body processes the drug – including how much drug reaches the bloodstream (AUC), maximum concentration levels (Cmax), how quickly the drug reaches peak levels (Tmax), how the body clears the drug (CL/F), and how long the drug stays in the body (half-life).
  • How long do participants stay in the ORG-129 study? The duration varies depending on which part of the study a participant joins. For the single ascending dose (SAD) portion, participants are monitored from day 1 through day 8. For the multiple ascending dose (MAD) portion, participants are followed from day 1 through day 12. Specific measurements are taken at various timepoints, such as days 1, 2, 5, and 10, depending on the study cohort.

Ongoing Clinical Trials on ORG-129

  • A study of the effects of AGMB-129 and midazolam in healthy participants

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium

  • Study on the Safety and Effects of ORG-129 in Patients with Fibrostenotic Crohn’s Disease

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Austria Denmark Germany Italy Poland Spain

Glossary

  • First in Human Study: The initial clinical trial of a new drug in human participants, typically conducted in healthy volunteers to assess basic safety and how the body processes the drug.
  • ORG-129: The investigational drug being studied in this clinical trial, administered as oral capsules.
  • Pharmacokinetics (PK): The study of how drugs move through the body, including absorption, distribution, metabolism, and elimination.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is available to have an active effect.
  • Single Ascending Dose (SAD): A study design where participants receive a single dose of the drug, with different groups receiving increasingly higher doses to assess safety and tolerance.
  • Multiple Ascending Dose (MAD): A study design where participants receive multiple doses of the drug over time, with different groups receiving increasingly higher doses.
  • Food Interaction: Assessment of how taking a drug with food affects how the body absorbs and processes the medication.
  • Placebo: An inactive substance (like a sugar pill) that looks identical to the study drug but has no therapeutic effect, used for comparison.
  • Placebo Comparator: The control group that receives a placebo instead of the active drug to compare outcomes.
  • Treatment Emergent Adverse Events: Side effects or unwanted reactions that appear after treatment begins and weren't present before.
  • AUC (Area Under the Curve): A measurement of the total drug exposure over time in the body.
  • Cmax: The maximum concentration of a drug observed in the bloodstream after administration.
  • Tmax: The time it takes for a drug to reach its maximum concentration in the bloodstream.
  • CL/F (Oral Clearance): A measure of how quickly the body eliminates a drug after oral administration.
  • Vz/F (Terminal Phase Volume of Distribution): A measure of how widely a drug is distributed throughout the body tissues compared to the bloodstream.
  • Kel (Elimination Rate): The rate at which a drug is removed from the body.
  • t 1/2 (Elimination Half-life): The time it takes for the concentration of a drug in the body to be reduced by half.
  • Css (Concentration at Steady State): The relatively constant drug concentration achieved in the body after repeated dosing when the rate of drug administration equals the rate of drug elimination.
  • C trough: The lowest concentration of a drug in the bloodstream before the next dose is administered during multiple dosing regimens.
  • Biomarker: A measurable indicator that can be used to determine how the body is responding to a treatment.
  • Cohort: A group of participants in a study who share a common characteristic or experience.
  • PK/PD: Pharmacokinetics/Pharmacodynamics – the study of both how the body processes a drug and how the drug affects the body.

References

  1. https://clinicaltrials.gov/study/NCT04933565