Healthy
Conditions
Brief summary
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
DRUGAramchol
Aramchol tablet at 2 different single doses
Sponsors
Galmed Pharmaceuticals Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
This will be an open-label study
Intervention model description
Each participant will attend 2 trial sessions in a crossover design with a wash-out interval of at least 14 days between dosing in each session.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed peak concentration (Cmax) of Aramchol | 2 months | Blood samples will be collected for pharmacokinetics characterization. Cmax will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. |
| Time to reach maximum concentration (Tmax) of Aramchol | 2 months | Blood samples will be collected for pharmacokinetics characterization. Tmax will be calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics |
| Area under the plasma curve (AUC) of Aramchol | 2 months | Blood samples will be collected for pharmacokinetics characterization. AUC of Aramchol will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimum observed concentration (Cmin) of Aramchol | 2 months | Blood samples will be collected for pharmacokinetics characterization. Cmin will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. |
| Terminal elimination half life (T1/2) of Aramchol | 2 months | Blood samples will be collected for pharmacokinetics characterization. T1/2 will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. |
| Average observed concentration (Cavg) of Aramchol | 2 months | Blood samples will be collected for pharmacokinetics characterization. Cavg will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. |
| Safety and tolerability of Aramchol | 2 months | The number of participants with treatment-related adverse events, as assessed by CTCAE v4.0 |
Countries
United Kingdom
Contacts
CONTACTYossi Gilgun-Sherki, PhD, MBA
PRINCIPAL_INVESTIGATORChristina Yeung, MBBS
Hammersmith Medicines Research
Outcome results
None listed