A multiple dose study to investigate the safety of ACH-0144471 in healthy volunteers
- Conditions
- Complement-mediated diseases.Inflammatory and Immune System - Autoimmune diseases
- Registration Number
- ACTRN12616000568415
- Lead Sponsor
- Achillion Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 46
1. Healthy male and female subjects of any ethnic origin between the ages of 25 and 55 years, inclusive
2. Body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
3. Female subjects must be of non-childbearing potential
4. Male subjects must agree to abstinence or use a condom when engaged in sexual activity
1. History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease in the opinion of the Principal Investigator (PI)
2. Any condition possibly affecting drug absorption (including gastrectomy or cholecystectomy)
3. Subjects with C3 complement protein (C3) or C4 complement protein (C4) >110% of the upper limit or <90% of the lower limit of the reference ranges at Screening
4. Subjects with alternative pathway hemolysis (AH50), or classical pathway hemolysis (CH50) assay results outside the reference ranges at Screening
5. Body temperature greater than or equal to 38 degrees C on Day – 1 or Day 1, Hour 0
6. History of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration
7. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection
8. Current tobacco users and smokers (defined as the use of any tobacco or nicotine-containing product within 3 months prior to first study drug administration) or a positive cotinine test at Screening or Day -1
9. History of hypersensitivity reactions to beta-lactams, penicillin, aminopenicillins, flouroquinolones (specifically including ciprofloxacin), cephalosporins, and carbapenems.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of multiple, ascending oral doses of ACH-0144471 in healthy volunteers.<br><br>This outcome is assessed using the following tests and assessments:<br>Assessment of AEs/SAEs, recording concomitant medications, obtaining vitals, ECGs and collection of blood and urine samples. Previous Human Experience with ACH-0144471 is limited, not allowing for examples of known/possible adverse reactions/events [Days -1 through 14, then approximately weekly through Day 42]
- Secondary Outcome Measures
Name Time Method