Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Concert Pharmaceuticals
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Adult males or females aged 18-75
Body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2 at the time of screening
If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication
Capable of giving informed consent and complying with study procedures
eGFR of 30-59 mL/minute/1.73 m2 as calculated by the MDRD equation
No clinically significant change in disease status within the last 30 days before screening
The subject must have a condition consistent with renal impairment and associated symptoms, but otherwise be determined to be in good health in the opinion of the Investigator
Concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed with the exception of strong CYP3A4 inhibitors and inducers
You may not be if
History of any clinically significant medical condition, psychiatric disease, social condition, or illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
Known history of any gastrointestinal surgery or any condition possibly affecting drug absorption
History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) \> 470 msec for males or QTcF \> 480 msec for females at Screening visit
Positive for human immunodeficiency virus, Hepatitis B virus, or Hepatitis C virus
Females who are nursing or pregnant prior to drug administration
Positive results for coronavirus infection (COVID-19) at screening or check-in
Positive drugs of abuse or alcohol results at screening or check in (Day -1)
History of renal transplant
Significant bleeding diathesis that could preclude multiple venipuncture or deep intramuscular injections
Acute or exacerbating renal disease
History of drugs of abuse or alcohol misuse within 6 months prior to screening
Poorly controlled Type 1 or Type 2 diabetes
Clareo Health | Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543
