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

RecruitingPhase 1

Sponsor: Galmed Pharmaceuticals Ltd

Conditions: Healthy

Interventions: Aramchol

Countries: United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (1)

London, United Kingdom