Celerion
Lincoln, Nebraska, 68502, United States
NCT Number: NCT07652697
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.
Looking for future studies?
Notify Me19 year–55 year
All sexes
Interventional
Phase 1
Lincoln, Nebraska, 68502, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ABX-002 was supplied as a solution and solid dose form.
Time frame: 8 weeks
Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001
Time frame: 8 weeks
Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001
Time frame: 8 weeks
Change in Peak Plasma Concentration for ABX-002 and LL-340001
Time frame: 8 weeks
Change in Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001
Time frame: 8 weeks
Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001
Time frame: 8 weeks
Change in Peak Plasma Concentration for ABX-002 and LL-340001
Time frame: 8 weeks
Incidence and severity of treatment-emergent adverse events to ABX-002 will be measured
Autobahn Therapeutics, Inc.
Industry
A Phase 1, Open-Label, Randomized, Single Dose Three-Way Crossover Study to Evaluate the Bioequivalence of, and the Effect of Food on, ABX-002 in Healthy Adult Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06840925
Healthy
Melbourne, Victoria, Australia
View Trial DetailsNCT01866852
Healthy
Bethesda, Maryland, United States
View Trial DetailsNCT05370222
Behavior, Behavior, Animal
Clermont-Ferrand, AURA, France
View Trial DetailsNCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial Details