Trial Outcomes & Findings for Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets (NCT NCT06502561)
NCT ID: NCT06502561
Last Updated: 2026-06-01
Results Overview
Observed maximal concentration after administration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
8 days 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
Results posted on
2026-06-01
Participant Flow
42 subjects were screened and 26 subjects were screening failures, so eventually 16 subjects were recruited to Period 1
A washout period of 74-95 days was implemented between Period 1 and Period 2. Another washout period of 14-15 days was implemented between randomization to Period 2 or Period 3 (Crossover parts)
Participant milestones
| Measure |
400 mg of Aramchol Meglumine (AM)
In Period 1, a single dose of Aramchol meglumine (AM) 400 mg will be administered to all study subjects (16) in Period 1
Aramchol meglumine is a salt form of Aramchol free acid
|
Aramchol Meglumine to Aramchol Free Acid
Subjects randomized to a single dose of 200 mg Aramchol meglumine (Test 2) in Period 2, then a single dose of 300 mg Aramchol free acid (Reference) in Period 3
Aramchol meglumine is a salt form of Aramchol free acid
Aramchol free acid is a fatty acid-bile acid conjugate
|
Aramchol Free Acid to Aramchol Meglumine
Subjects randomized to a single dose of of 300 mg Aramchol free acid (Reference) in Period 2 and then to 200 mg Aramchol meglumine (Test 2) in Period 3
Aramchol free acid is a fatty acid-bile acid conjugate
Aramchol meglumine is the salt form of Aramchol free acid
|
|---|---|---|---|
|
Period 1- 400 mg AM- 8 Days
STARTED
|
16
|
0
|
0
|
|
Period 1- 400 mg AM- 8 Days
COMPLETED
|
14
|
0
|
0
|
|
Period 1- 400 mg AM- 8 Days
NOT COMPLETED
|
2
|
0
|
0
|
|
Period 2- 200 mg AM or 300 mg AA- 8 Days
STARTED
|
0
|
8
|
6
|
|
Period 2- 200 mg AM or 300 mg AA- 8 Days
COMPLETED
|
0
|
6
|
6
|
|
Period 2- 200 mg AM or 300 mg AA- 8 Days
NOT COMPLETED
|
0
|
2
|
0
|
|
Period 3- 300 mg AA or 200 mg AM- 8 Days
STARTED
|
0
|
6
|
6
|
|
Period 3- 300 mg AA or 200 mg AM- 8 Days
COMPLETED
|
0
|
6
|
6
|
|
Period 3- 300 mg AA or 200 mg AM- 8 Days
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets
Baseline characteristics by cohort
| Measure |
All Study Participants
n=16 Participants
All subjects who participated in the study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 7.4 • n=24 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
Bulgaria
|
16 participants
n=24 Participants
|
|
Body Mass Index (BMI)
|
24.8 kg/m2
STANDARD_DEVIATION 3.27 • n=24 Participants
|
PRIMARY outcome
Timeframe: 8 days 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.Observed maximal concentration after administration
Outcome measures
| Measure |
400 mg Aramchol Meglumine
n=16 Participants
Subjects received a single dose of 400 mg dose of Aramchol meglumine.
Aramchol meglumine is a salt form of Aramchol free acid
|
200 mg Aramchol Meglumine
n=14 Participants
Subjects received a single dose of 200 mg Aramchol meglumine
Aramchol meglumine is a salt form of Aramchol free acid
|
300 mg Aramchol Free Acid
n=12 Participants
Subjects received a single dose of 300 mg Aramchol free acid
Aramchol free acid is a fatty acid-bile acid conjugate
|
|---|---|---|---|
|
Cmax of Aramchol
|
3.334 µg/mL
Geometric Coefficient of Variation 50.7
|
2.057 µg/mL
Geometric Coefficient of Variation 72.6
|
0.668 µg/mL
Geometric Coefficient of Variation 41.6
|
PRIMARY outcome
Timeframe: 8 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.Area under the concentration/time curve to the last measurable concentration, calculated by the trapezoidal rule from time 0 h to last observed concentration at time t
Outcome measures
| Measure |
400 mg Aramchol Meglumine
n=16 Participants
Subjects received a single dose of 400 mg dose of Aramchol meglumine.
Aramchol meglumine is a salt form of Aramchol free acid
|
200 mg Aramchol Meglumine
n=12 Participants
Subjects received a single dose of 200 mg Aramchol meglumine
Aramchol meglumine is a salt form of Aramchol free acid
|
300 mg Aramchol Free Acid
n=12 Participants
Subjects received a single dose of 300 mg Aramchol free acid
Aramchol free acid is a fatty acid-bile acid conjugate
|
|---|---|---|---|
|
AUClast of Aramchol
|
146.525 µg*h/mL
Geometric Coefficient of Variation 57.9
|
94.671 µg*h/mL
Geometric Coefficient of Variation 63.3
|
31.342 µg*h/mL
Geometric Coefficient of Variation 53.7
|
PRIMARY outcome
Timeframe: 8 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.Area under the concentration/time curve, from time 0 h extrapolated to infinity
Outcome measures
| Measure |
400 mg Aramchol Meglumine
n=16 Participants
Subjects received a single dose of 400 mg dose of Aramchol meglumine.
Aramchol meglumine is a salt form of Aramchol free acid
|
200 mg Aramchol Meglumine
n=12 Participants
Subjects received a single dose of 200 mg Aramchol meglumine
Aramchol meglumine is a salt form of Aramchol free acid
|
300 mg Aramchol Free Acid
n=12 Participants
Subjects received a single dose of 300 mg Aramchol free acid
Aramchol free acid is a fatty acid-bile acid conjugate
|
|---|---|---|---|
|
AUCinf of Aramchol
|
160.193 µg*h/mL
Geometric Coefficient of Variation 54.8
|
101.094 µg*h/mL
Geometric Coefficient of Variation 63.8
|
34.365 µg*h/mL
Geometric Coefficient of Variation 53.7
|
SECONDARY outcome
Timeframe: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.Observed time point of maximal concentration
Outcome measures
| Measure |
400 mg Aramchol Meglumine
n=16 Participants
Subjects received a single dose of 400 mg dose of Aramchol meglumine.
Aramchol meglumine is a salt form of Aramchol free acid
|
200 mg Aramchol Meglumine
n=12 Participants
Subjects received a single dose of 200 mg Aramchol meglumine
Aramchol meglumine is a salt form of Aramchol free acid
|
300 mg Aramchol Free Acid
n=12 Participants
Subjects received a single dose of 300 mg Aramchol free acid
Aramchol free acid is a fatty acid-bile acid conjugate
|
|---|---|---|---|
|
Tmax of Aramchol
|
14.00 hours
Interval 8.0 to 14.017
|
12.00 hours
Interval 10.0 to 14.0
|
14.00 hours
Interval 10.0 to 36.0
|
SECONDARY outcome
Timeframe: 8 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.Terminal rate constant in both study periods
Outcome measures
| Measure |
400 mg Aramchol Meglumine
n=16 Participants
Subjects received a single dose of 400 mg dose of Aramchol meglumine.
Aramchol meglumine is a salt form of Aramchol free acid
|
200 mg Aramchol Meglumine
n=12 Participants
Subjects received a single dose of 200 mg Aramchol meglumine
Aramchol meglumine is a salt form of Aramchol free acid
|
300 mg Aramchol Free Acid
n=12 Participants
Subjects received a single dose of 300 mg Aramchol free acid
Aramchol free acid is a fatty acid-bile acid conjugate
|
|---|---|---|---|
|
λz of Aramchol
|
0.0197 1/hour
Geometric Coefficient of Variation 29.4
|
0.0157 1/hour
Geometric Coefficient of Variation 23.0
|
0.0158 1/hour
Geometric Coefficient of Variation 36.0
|
SECONDARY outcome
Timeframe: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.Plasma concentration half-life
Outcome measures
| Measure |
400 mg Aramchol Meglumine
n=16 Participants
Subjects received a single dose of 400 mg dose of Aramchol meglumine.
Aramchol meglumine is a salt form of Aramchol free acid
|
200 mg Aramchol Meglumine
n=12 Participants
Subjects received a single dose of 200 mg Aramchol meglumine
Aramchol meglumine is a salt form of Aramchol free acid
|
300 mg Aramchol Free Acid
n=12 Participants
Subjects received a single dose of 300 mg Aramchol free acid
Aramchol free acid is a fatty acid-bile acid conjugate
|
|---|---|---|---|
|
t½ of Aramchol
|
35.117 hours
Geometric Coefficient of Variation 29.4
|
44.108 hours
Geometric Coefficient of Variation 23.0
|
43.944 hours
Geometric Coefficient of Variation 36.0
|
SECONDARY outcome
Timeframe: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.Clearance per fraction of bioavailability
Outcome measures
| Measure |
400 mg Aramchol Meglumine
n=16 Participants
Subjects received a single dose of 400 mg dose of Aramchol meglumine.
Aramchol meglumine is a salt form of Aramchol free acid
|
200 mg Aramchol Meglumine
n=14 Participants
Subjects received a single dose of 200 mg Aramchol meglumine
Aramchol meglumine is a salt form of Aramchol free acid
|
300 mg Aramchol Free Acid
n=12 Participants
Subjects received a single dose of 300 mg Aramchol free acid
Aramchol free acid is a fatty acid-bile acid conjugate
|
|---|---|---|---|
|
CL/F of Aramchol
|
2.890 L/h
Standard Deviation 1.978
|
2.419 L/h
Standard Deviation 1.458
|
9.842 L/h
Standard Deviation 5.319
|
SECONDARY outcome
Timeframe: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.Volume of distribution per fraction of bioavailability
Outcome measures
| Measure |
400 mg Aramchol Meglumine
n=16 Participants
Subjects received a single dose of 400 mg dose of Aramchol meglumine.
Aramchol meglumine is a salt form of Aramchol free acid
|
200 mg Aramchol Meglumine
n=14 Participants
Subjects received a single dose of 200 mg Aramchol meglumine
Aramchol meglumine is a salt form of Aramchol free acid
|
300 mg Aramchol Free Acid
n=12 Participants
Subjects received a single dose of 300 mg Aramchol free acid
Aramchol free acid is a fatty acid-bile acid conjugate
|
|---|---|---|---|
|
VZ/F of Aramchol
|
135.40 L
Standard Deviation 59.246
|
147.93 L
Standard Deviation 80.241
|
617.65 L
Standard Deviation 331.358
|
SECONDARY outcome
Timeframe: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.The percentage of the area under the concentration-time curve (%AUC) that is extrapolated beyond the last observed data point
Outcome measures
| Measure |
400 mg Aramchol Meglumine
n=16 Participants
Subjects received a single dose of 400 mg dose of Aramchol meglumine.
Aramchol meglumine is a salt form of Aramchol free acid
|
200 mg Aramchol Meglumine
n=12 Participants
Subjects received a single dose of 200 mg Aramchol meglumine
Aramchol meglumine is a salt form of Aramchol free acid
|
300 mg Aramchol Free Acid
n=12 Participants
Subjects received a single dose of 300 mg Aramchol free acid
Aramchol free acid is a fatty acid-bile acid conjugate
|
|---|---|---|---|
|
%AUCextrap of Aramchol
|
8.74 % of extrapolated AUC
Standard Deviation 3.33
|
6.34 % of extrapolated AUC
Standard Deviation 1.82
|
8.71 % of extrapolated AUC
Standard Deviation 4.12
|
Adverse Events
400 mg Dose of Aramchol Meglumine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
200 mg Aramchol Meglumine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
300 mg Aramchol Free Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Yossi Gilgun-Sherki, PhD, Executive Drug Development Consultant
Galmed Pharmaceuticals
Phone: 972543314054
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place