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Pharmacokinetics Of Orally Administered Fx-1006A In Subjects With Hepatic Dysfunction

NCT01358565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2011-06-23

No results posted yet for this study

Summary

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.

Conditions

  • Mild Hepatic Dysfunction
  • Moderate Hepatic Dysfunction

Interventions

DRUG

Fx-1006A

A single oral 20 mg dose of Fx-1006A will be administered on Day 1 followed by 16 days of follow-up.

DRUG

Fx-1006A

A single oral 20 mg dose of Fx-1006A will be administered on Day 1 followed by 16 days of follow-up.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • South Africa

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358565 on ClinicalTrials.gov