A Phase 1 interventional study of CTP-543 in Renal Impairment, sponsored by Concert Pharmaceuticals. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Concert Pharmaceuticals · Phase 1, Interventional, and Basic science
This is an open-label, single-dose, sequentially designed, single-period study to determine the effect of moderate renal impairment on the pharmacokinetics (PK) of CTP-543 and its major metabolites following administration of a single 12 mg oral dose of CTP-543.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 16 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Concert Pharmaceuticals is the lead sponsor of 32 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 7 (37%) have results posted.
Counted across the registry records on this site, refreshed daily.
Additional Inclusion Criteria for Subjects with Renal Impairment:
Exclusion Criteria:
Additional Exclusion Criteria for Subjects with Renal Impairment:
Drug: CTP-543
Single 12 mg oral dose administered on Day 1
Single dose PK exposure: Maximum observed concentration (Cmax)
Maximum concentration, obtained directly from the observed concentration versus time data.
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours post-dose
Single dose PK exposure: Area Under the Concentration-Time Curve from time zero to the time of the last observed/measured non-zero concentration (AUC0-t)
Area under the concentration-time curve from time zero (pre-dose) to time of last measurable concentration (calculated by linear-log trapezoidal summation)
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours post-dose
Single dose PK exposure: Area Under the Concentration-Time Curve from time 0 extrapolated to infinity (AUC0-inf)
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity, calculated by linear-log trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the elimination rate constant
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours post-dose
Assessment of Safety and Tolerability following administration of CTP-543
Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject
Time frame: Screening (within 21 days prior to Day 1) through follow-up (7 to 10 days after final drug)
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Concert Pharmaceuticals