This an open label study to assess the pharmacokinetics of CT1812 in normal healthy volunteers.
Open label study to assess PK in 36 older healthy volunteers. Subjects will be screened 35 days prior dose to determine eligibility. On day -1 subjects will be admitted to the clinical research unit and on day 1 will be randomized to receive one of the following doses: 150 mg BID, 150 mg QD or 300 mg QD in the fed state. Subjects will be confined in the Clinical Research Unit where they will continue to receive study drug and complete safety assessments, PK and CSF draws, until day 16 when they will be discharged.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
35
Study Drug
Accel Clinical Research
DeLand, Florida, United States
Pharmacokinetics (PK) in plasma
Cmax: Maximum observed plasma concentration occurring at Tmax
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
Tmax: The first time to maximum observed concentration sampled during a dosing interval.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
Ctau: Concentration at the end of the dosing interval (12 hr for BID group; 24 hr for QD group).
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC 0-12h: Area under the concentration-time curve (AUC) from time 0 to 12 hours post-dose.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC 0-24h: AUC from time 0 to 24 hours post-dose.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC 0-last: AUC from time 0 to the time of the last measurable concentration at 48 and 72 hours as applicable.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC 0-inf: Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity, calculated using the observed value of the last non-zero concentration.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
AUC\_%Extrap: Percent of AUC0-inf contributed by extrapolation beyond AUC0-last.
Time frame: Day 13 and 15.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacokinetics (PK) in plasma
λz : Terminal elimination phase rate constant.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in plasma
t½: Terminal phase half-life.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Cmax - Maximum observed plasma concentration occurring at Tmax.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Tmax -The first time to maximum observed concentration sampled during a dosing interval.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Cavg,ss - Average plasma concentration at steady-state interval.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Ctau-Concentration at the end of the dosing interval (12 hr for BID group; 24 hr for QD group).
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Fluctuation (%) - Fluctuation (%) between maximum and minimum concentrations over the steady-state dosing interval.
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
AUC-0-tau - Area under the concentration-time curve from time 0 to the end of the dosing interval (0-12 for the BID group; 0 - 24 for the QD groups) .
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
λz- Terminal elimination phase rate constant
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
t½ - Terminal phase half-life
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
AUCcum- Accumulation ratio in AUC, calculated as AUC0-tau,ss/AUC0-tau,D1
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Ctau,cum- Accumulation ratio in Ctau, calculated as Ctau,ss/Ctau,D1
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF).
Cmax,cum - Accumulation ratio in Cmax, calculated as Cmax,ss/Cmax,D1
Time frame: Day 13 and 15.
Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF)- CSF/plasma ratio
CSF/plasma ratio - Pre-dose on Day 13 and 3h (±15 min) post-dose on Day 15
Time frame: Day 13 and 15.