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Recruiting NCT07251712

Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From an Aramchol Meglumine Tablet

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aramchol.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Open-label Trial in Healthy Volunteers to Evaluate the Exposure of Aramchol From Two Different Single Doses of an Aramchol Meglumine Tablet

Overview

Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine tablet.

Detailed description

Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine given one daily with that from a 300 mg dose of Aramchol free acid tablets given twice daily in adult Healthy volunteers.

Interventions

  • Drug Aramchol
    Aramchol tablet at 2 different single doses

Primary outcome measures

  • Maximum observed peak concentration (Cmax) of Aramchol [Time frame: 2 months]
  • Time to reach maximum concentration (Tmax) of Aramchol [Time frame: 2 months]
  • Area under the plasma curve (AUC) of Aramchol [Time frame: 2 months]
Secondary outcome measures (4)
  • Minimum observed concentration (Cmin) of Aramchol [Time frame: 2 months]
  • Terminal elimination half life (T1/2) of Aramchol [Time frame: 2 months]
  • Average observed concentration (Cavg) of Aramchol [Time frame: 2 months]
  • Safety and tolerability of Aramchol [Time frame: 2 months]

Eligibility criteria

Inclusion criteria

  • Male or female healthy volunteers with body mass index (BMI) in the range of 18-30.9 kg/ m2 inclusive
  • Deemed healthy on the basis of clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
  • Agree to follow-up the contraception requirements of the trial
  • Able to give fully informed written consent

Exclusion criteria

  • Females of reproductive potential who are pregnant or lactating
  • Positive tests for hepatitis B, C or HIV
  • History of sever adverse reaction to any drug
  • Known sensitivity to drug medication
  • Drug or alcohol abuse
  • Smoking in the 3 months prior the study
  • Clinically relevant abnormal lab results, medical history or concurrent medical condition
  • Evidence of acute or chronic disease
  • Inability to adhere to study requirements

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Hammersmith Medicines Research (HMR) — London

Identifiers

NCT: NCT07251712 · AM-003 · 1013148 · IRAS number- 1013148

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗