A Study to Determine the Effect of ACH-0144471 on Subjects With HI Compared to Healthy Matches
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/11/2019 |
Start Date: | May 15, 2018 |
End Date: | September 21, 2018 |
A Phase 1, 2-Part, Open-label, Single-Dose, Parallel Group Study to Determine the Effect of Hepatic Impairment on the Safety, Tolerability, and Pharmacokinetics of ACH-0144471 in Adult Subjects
The purpose of this study is to determine if ACH-0144471 has any effects on participants with
HI compared to healthy matched participants as it relates to safety, tolerability and PK.
HI compared to healthy matched participants as it relates to safety, tolerability and PK.
Inclusion Criteria:
- Adult males or females, between 18 and 75
- Body mass index range of 18.0 to 40.0 kg/m2 with a minimum body weight of 50 kg at
screening
- Females must be of non-childbearing potential
- Males must agree to abstinence or use highly effective method of contraception
- Able to comprehend and willing to sign informed consent
Hepatic Impairment Subjects:
- Be sufficiently healthy for study participation
- Diagnosis of chronic (> 6 months) stable hepatic insufficiency
- A stable medication regimen
- In good general health at screening and check-in, allowing for the concurrent
illnesses associated with hepatic impairment
- Evidence of cirrhosis
- Cirrhosis due to Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) infection,
cryptogenic, alcohol abuse or Nonalcoholic steatohepatitis (NASH)
- No evidence of hepatocellular carcinoma
- Have hepatic impairment as assessed by a Child Pugh classification score at screening
Healthy Subjects:
- Subjects must be demographically matched to a hepatically impaired subject
- Medically healthy with clinically significant medical history
Exclusion Criteria:
- Evidence of any others clinically significant deviation from normal in clinical
laboratory for the match controlled subjects and laboratory findings beyond those
which are consistent with the degree of hepatic impairment fro hepatic subjects
- History of any medical or psychiatric condition or disease
- History or presence of drug or alcohol abuse within 6 months prior to dosing
- History or presence of clinically significant hypersensitivity or idiosyncratic
reaction to the study drug or related compounds.
- History of clinically significant hypersensitivity reactions to commonly used
antibacterial agents
- History of febrile illness, or other evidence of infection within 14 days prior to
dosing
- History of meningococcal infection or a first-degree relative with a history of
meningococcal infection
- Any previous procedure that could alter absorption or excretion of orally administered
drugs
- Prior history or current evidence of hepatobiliary cholestasis
- Diagnosis or history of Gilbert's syndrome
- Any major surgery within 4 weeks of dosing
- Is a female with a positive pregnancy test or lactating
- Subjects with Complement Total (CH50) results outside of reference ranges at screening
- Positive results of human immunodeficiency virus (HIV) at screening
- Body temperature greater than or equal to 38 degrees centigrade on Day -1 or Day 1
prior to dosing
- Heavy smoker or use of nicotine products from screening through the period of PK
sample collection
- Subjects who have received eculizumab at any dose or interval within the past 75 days
- Participation in any other investigational study drug trial 30 days before dosing
- Subjects who consume an average of more than 8 cups of coffee or other caffeinated
beverage or 7 cans of cola per day
- Poor peripheral venous access
- Donation of whole blood from 3 months before dosing, or of plasma from 30 days before
dosing
- Receipt of blood products within 6 months before dosing
- Receipt of a vaccine within 30 days before dosing
- Presence of history of malignancy
- Positive drugs-of-abuse at screening or check-in
- Consumption of any alcohol within 72 hours before dosing or a history of regular
alcohol consumption exceeding 21 drinks/week
- Positive results for urine or breath alcohol at screening or check-in
- Serum creatinine > upper limit of normal (ULN) or creatinine clearance < 80mL/min Use
of any drugs known to be strong inhibitors or inducers of P-glycoprotein (P-gp)
hepatic impairment subjects
- Any acute or chronic non-hepatic condition that would limit the subjects ability to
participate in this study
- Any other unspecified reason that would make the subject unsuitable for enrollment
- Any screening laboratory evaluation outside the laboratory reference ranges not
related to hepatic impairment
- In the opinion of the Investigator and Sponsor, fluctuating or rapidly deteriorating
hepatic function within the screening period and up to 30 days prior to Day 1
- History of chronic liver disease due to Wilson's disease
- History of liver or other solid organ transplant healthy subjects
- Clinical laboratory evaluations outside of the reference range at screening or
check-in
- Evidence of acute or chronic liver disease
- Use of any prescription medications/products within 14 days prior to dosing
- Use of an over-the-counter, nonprescription preparations within 7 days prior to dosing
- Evidence of chronic HBV or chronic HCV infection
We found this trial at
2
sites
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
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