Phase 1
N=57
Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment
Hepatic Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04480827 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: AUC0-tau, Steady State — 96100; 107000; 103000; 69500 h•ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Aramchol free acid tablet 600mg, single dose (Drug); Aramchol free acid tablet 300mg, bid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galmed Research and Development, Ltd.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-tau, Steady State |
96100; 107000; 103000; 69500; 63300; 55900 | — |
| PRIMARY Cmax,ss |
1950; 1890; 1480; 1410; 5750; 5380 | — |
| PRIMARY Apparent Total Oral Clearance, Single Dose |
5.96; 5.23; 5.86; 8.01 | — |
| SECONDARY Number of Subjects With Significant TEAEs |
0; 0; 0; 0; 0; 0 | — |
Summary
Phase 1, multicenter, open-label, 2-part, single- and multiple-dose study designed to assess the effect of hepatic insufficiency on the PK of aramchol
Eligibility Criteria
Inclusion Criteria
- The subject is male or female 18 to 79 years of age, inclusive.
- The subject has a body mass index of 19 to 40 kg/m2, inclusive, at screening.
- Females of childbearing potential must practice a highly effective method of contraception throughout the study period and for 1 month after treatment discontinuation.
- Male subjects with female partners of childbearing potential must be vasectomized, be willing to use an acceptable method of birth control, or practice abstinence during the study.
- The subject has a resting pulse rate of ≥40 and 15 units per week) (1 unit is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
- The subject smokes >10 cigarettes daily and is unwilling to reduce to 450 mL within 3 months before the first dose of study drug.
- The subject has a presence or history of relevant drug and/or food allergies (ie, allergy to aramchol, cholic acid, or any excipients, or any significant food allergy.
- The subject has received study drug in another investigational study within 30 days of dosing.
- In the opinion of the investigator, the subject is not suitable for entry into the study.
For additional exclusion criteria specific to hepatic impaired subjects and healthy volunteers, see protocol.
Data sourced from ClinicalTrials.gov (NCT04480827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.