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

This is an interventional basic science trial for Mild Hepatic Dysfunction Read More

Inclusion Criteria:

All Subjects

• Subject is male or female (female subjects must be of non-child-bearing potential or willing to use a medically acceptable form of birth control during the study).
• Subject is between 18 to 70 years of age, inclusive.
• Subject is a cigarette smoker, consuming less than 15 cigarettes per day.
• Subject has given written informed consent.

Hepatic Dysfunction Subjects:

• Subject has hepatic dysfunction:

  1. Study Stage 1: Subject has moderate hepatic dysfunction (Child-Pugh score of 7-9, inclusive)
  2. Study Stage 2 (if commenced): Subject has mild hepatic dysfunction (Child-Pugh score of 5-6, inclusive)
• 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:

  1. A pre-study physical examination with no clinically significant abnormalities
  2. Vital signs within normal ranges
  3. An ECG with no clinically significant abnormalities
• 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:

• Subject has had a clinically significant illness in the four (4) weeks before screening.
• Subject shows evidence of a clinically significant underlying medical condition, including renal, cardiovascular, or metabolic dysfunction that, in the opinion of the Investigator, would represent a risk of study participation.
• Subject has any other clinically significant laboratory abnormality, as determined by the Investigator, within 21 days before dosing on Day 1.
• Subject has a history of clinically important disease that, in the opinion of the investigator, may put the subject at risk because of participation in this study.
• Subject is enrolled or plans to enroll in another clinical trial during this study or has received an investigational drug/device within 60 days before Day 1.
• Subject is known to be hepatitis B surface antigen (HbsAg) positive, anti-hepatitis C antibody (anti-HCV) positive, or human immunodeficiency virus (HIV) positive, or has any positive result during Screening.
• Subject has a history of alcohol abuse, or illicit drug use, physical dependence to any opioid, or drug abuse or addiction.
• Subject has a history of significant mental illness.
• Subject has positive urine drug screen test results within 21 days before Day 1, excluding alcohol. Alcohol consumption is not permitted within 72 hours before Day 1.
• Subject has a history of complications associated with providing blood samples.
• Subject reports donating greater than 150 mL of blood or donating plasma via plasmapheresis within 28 days prior to enrollment. All subjects will be advised not to donate blood for four weeks after completing the study.

Hepatic Dysfunction Subjects:

• Subject has an encephalopathy grade > 1.
• Subject has any clinically significant laboratory abnormality not associated with underlying hepatic impairment, as determined by the Investigator, within 21 days before dosing on Day 1.
• Unless being used to treat the subject's underlying hepatic disease, the subject has taken an over the counter (OTC) medication (including non-steroidal anti-inflammatory drugs (NSAIDs) or herbal preparations) within 48 hours before Day 1.

Normal Hepatic Function Subjects:

• Use of prescription medications in the 14 days prior to Day 1.
• Subject has taken an OTC medication (including NSAIDs or herbal preparations) within 48 hours before Day 1.