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AMMONIUM (15N) CHLORIDE

Clinical trials are investigating AMMONIUM (15N) CHLORIDE in people with urea cycle disorders and in healthy volunteers. The study is looking at safety, tolerability, and other clinical measures in a Phase 1 setting. It also includes participants with an abnormal heterozygous ornithine transcarbamylase (OTC) genotype.

Table of Contents

Trial overview

The available trial for AMMONIUM (15N) CHLORIDE is NCT06247670, a Phase 1 study that is authorised and planned to enroll 144 people.[1] It is described as a double-blind, placebo-controlled, single and multiple ascending dose study of CMP-CPS-001 in healthy volunteers and participants with abnormal heterozygous ornithine transcarbamylase (OTC) genotype.[1]

The trial is linked to urea cycle disorders (UCD), which are the conditions being studied in this research.[1] The brief summary says the main purpose is to evaluate the safety and tolerability of CMP-CPS-001 when given subcutaneously, while AMMONIUM (15N) CHLORIDE is one of the listed interventions in the study.[1]

Who can participate

This study includes healthy volunteers and people with an abnormal heterozygous OTC genotype.[1] In simple terms, that means the researchers are studying both people without the disease and people with a specific genetic change related to OTC.[1]

The trial does not list detailed public eligibility rules in the provided data, so the main known target groups are the two groups named in the title.[1]

What the study measures

The primary outcome measures are incidence of adverse events, vital signs, ECG, clinical laboratory assessment, and physical examination.[1] These are standard ways to check whether participants stay safe during a trial and whether any changes happen in the body.[1]

Adverse events are any unwanted medical problems that happen during the study, whether or not they are caused by the treatment.[1] Vital signs, ECG, lab tests, and physical exams help the research team watch for changes in heart function, body systems, and overall health.[1]

Study design and phase

The study is interventional, which means participants receive study treatments as part of the research plan.[1] It is also double-blind and placebo-controlled, meaning neither the participants nor the study team may know who gets the active study treatment or placebo during the trial.[1]

The title also says the study uses single and multiple ascending dose parts.[1] This means the researchers are testing different dose levels over time to learn more about safety in a careful step-by-step way.[1]

AMMONIUM (15N) CHLORIDE is listed among the interventions as an oral drug, while the study also includes sodium chloride for injection, [13C]sodium acetate given orally, and CMP-CPS-001 given subcutaneously.[1]

What this means for patients

For patients and families, this trial is mainly about early research rather than proving that a treatment works in everyday care.[1] The focus is on whether the study approach is safe and tolerable in people with urea cycle disorders and in healthy volunteers.[1]

Because this is a Phase 1 study, the results are usually used to guide later research, not to make final treatment decisions.[1] The data provided do not include final results, so the main information available is the study purpose, the groups being studied, and the safety measures being tracked.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06247670 Phase 1 Urea cycle disorders (UCD) Authorised 144

FAQ

  • What is being studied in the AMMONIUM (15N) CHLORIDE trial? The trial is part of a Phase 1 study that evaluates CMP-CPS-001 and includes AMMONIUM (15N) CHLORIDE as an oral intervention. The main goal is to assess safety and tolerability.
  • Who can take part in this study? The study includes healthy volunteers and participants with an abnormal heterozygous ornithine transcarbamylase (OTC) genotype. These groups help researchers compare how the study is handled in different participants.
  • What condition is linked to this trial? The trial is connected to urea cycle disorders, also called UCD. These are conditions where the body has trouble processing nitrogen.
  • What phase is the study? This is a Phase 1 study. Phase 1 trials are usually early studies that focus on safety, tolerability, and basic clinical measurements.
  • What results are the researchers measuring? The main measures are adverse events, vital signs, ECG, clinical laboratory tests, and physical examination. These help show whether the study treatment is safe and how the body responds.

Ongoing Clinical Trials on AMMONIUM (15N) CHLORIDE

  • Study of CMP-CPS-001 injection in healthy volunteers and patients with abnormal ornithine transcarbamylase (OTC) genotype for treating urea cycle disorders

    Not yet recruiting

    1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Phase 1: An early type of clinical trial that mainly checks safety and tolerability in a small group of people.
  • Safety: Whether a treatment causes harmful effects or serious problems.
  • Tolerability: How well people can take a treatment without troublesome side effects or problems.
  • Healthy volunteers: People without the disease being studied who join a trial to help researchers compare results.
  • Urea cycle disorders (UCD): A group of rare conditions where the body cannot handle nitrogen normally.
  • Ornithine transcarbamylase (OTC) genotype: A genetic pattern related to the OTC gene. In this trial, participants have an abnormal heterozygous OTC genotype.
  • Heterozygous: Having two different versions of a gene, one from each parent.
  • Adverse events (AEs): Any unwanted medical problems that happen during a study, whether or not they are caused by the treatment.
  • Vital signs: Basic body measures such as blood pressure, pulse, temperature, and breathing rate.
  • ECG: A test that records the heart’s electrical activity.
  • Clinical laboratory assessment: Blood or urine tests used to check health and body function.
  • Physical examination: A doctor or study clinician checks the body for signs of illness or changes.

References