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This is a Phase I, open-label, single-dose study designed to assess the effects of hepatic dysfunction on the PK of orally administered Fx-1006A 20 mg soft gelatin capsules.
An adaptive 2-stage study design will be implemented. Initially (Stage 1), a group of 9 subjects with moderate hepatic dysfunction (Child-Pugh score of 7-9, inclusive) followed by a group of 9 healthy volunteer subjects with normal hepatic function who are comparable in age, gender, and weight to the hepatically impaired subjects will be enrolled to receive a single oral 20 mg dose of Fx-1006A each.
Data obtained from the first 2 groups will be analyzed and reviewed by the Sponsor to determine whether Fx-1006A PK is altered by hepatic dysfunction. If it is determined that hepatic dysfunction affects Fx-1006A PK, then Stage 2 will be commenced. During Stage 2, a group of 9 subjects with mild impairment (Child-Pugh score of 5-6, inclusive) will be enrolled to receive a single oral 20 mg dose of Fx-1006A each. Additional subjects with normal hepatic function may be enrolled to ensure appropriate demographic matching to the mild hepatically impaired subjects, with respect to age, gender, and weight.
During Screening, subjects will provide written informed consent to participate in the study and be reviewed against the study entrance criteria (including assessment of hepatic function) to determine eligibility. All subjects will provide blood and urine samples for clinical laboratory testing, drug testing, and pregnancy testing to determine eligibility.
Subjects who meet the entrance criteria during Screening will check in to the clinical site 1 day prior to dosing (Day 0) in the evening, and will be reviewed against the entrance criteria to confirm eligibility. Subjects will remain inpatient overnight for pre-dose assessments. Subjects will be fasted for a minimum of 8 hours prior to dosing the following day (water is allowed).
The single Fx-1006A dose will be administered on Day 1 under supervision of the Investigator or appropriate clinical site staff. Subjects will remain fasted for 4 hours after dosing (water is allowed) and will remain inpatient overnight for safety monitoring and PK sample collection.
Subjects will be discharged on Day 2, after they have completed the study procedures and the Investigator has determined that the subject is clinically stable. Subjects will return to the clinical site for out-patient visits on Days 3, 4, 6, 9, 12, and 16 for safety evaluations and PK sample collection. Day 16 will be the end of study visit.
Enrollment
Sex
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Inclusion criteria
All Subjects
Hepatic Dysfunction Subjects:
Subject has hepatic dysfunction:
Subject's hepatic disease is deemed stable by the Investigator.
Subject's pre-study clinical laboratory findings are within normal range or if outside of the normal range, deemed associated with underlying hepatic dysfunction or not clinically significant in the opinion of the Investigator and the sponsor.
Normal Hepatic Function Subjects:
Subject is considered to be in good health in the opinion of the Investigator, as determined by:
Subject's pre-study clinical laboratory findings are within normal range or if outside of the normal range not deemed clinically significant in the opinion of the Investigator and the Sponsor.
Exclusion criteria
Hepatic Dysfunction Subjects:
Normal Hepatic Function Subjects:
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16 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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