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Official title Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From an Aramchol Meglumine Tablet
ClinicalTrials.gov ID: NCT07251712
What this study is testing
What is Aramchol?
Aramchol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for healthy.
Also referred to as 3β-arachidylamino-7α,12α-dihydroxy-5β-cholan-24-oic acid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.