Healthy
Conditions
Keywords
Healthy Volunteers, Bioequivalence, Elunetirom
Brief summary
The goal of this study is to assess the bioequivalence (BE) between the liquid formulation and the new solid formulation of ABX-002 under fasting conditions and to evaluate the effect of food on the pharmacokinetics (PK) of the new solid formulation of ABX-002.This study design is consistent with FDA guidelines for the assessment of BE. This was an open label, randomized, single dose, three-way crossover BE and food-effect study. Therefore, the total number of participants in this study was 18.
Interventions
DRUGABX-002
ABX-002 was supplied as a solution and solid dose form.
Sponsors
Autobahn Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Participants received each treatment on one occasion. The treatment sequences participants were randomized to included: ABC, BCA, CAB, ACB, BAC, and CBA.
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting * BMI ≥ 18.0 and ≤ 32.0 kg/m2 and minimum weight of 50 kg at the screening visit * Medically healthy, as deemed by the PI or designee, with no clinically significant medical history, or clinically significant abnormalities in physical examination, clinical laboratory profiles, and vital signs * Capable of providing written informed consent, able to understand the nature of the trial and, in the opinion of the PI or designee, able to follow all protocol requirements including the schedule of assessments
Exclusion criteria
* Mentally or legally incapacitated or had significant emotional problems at the time of the screening visit or expected during the conduct of the study * History of any illness that, in the opinion of the PI or designee, might have confounded the results of the study or posed an additional risk to the participant * History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing * History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds * History of thyroid disease * History or presence of Clinically significant cataract, glaucoma, severe ocular trauma, inflammatory eye disease, or prior ophthalmic surgical procedures or laser surgery in either eye. * Clinically significant abnormalities on 12-lead ECG at the screening visit * Positive urine drug or alcohol results at the screening visit or check-in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation in healthy adult participants. | 8 weeks | Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001 |
| Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation | 8 weeks | Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants | 8 weeks | Change in Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001 |
| Evaluate the safety and tolerability of 3 total doses of ABX-002 in healthy adult participants. | 8 weeks | Incidence and severity of treatment-emergent adverse events to ABX-002 will be measured |
Countries
United States
Outcome results
None listed