A Phase 1 interventional study of Lu AF35700 in Renal Failure, sponsored by H. Lundbeck A/S. Terminated at 1 site in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment
This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects
If the initial data shows a substantial effect in subjects with severe renal impairment, the study will be expanded to include subjects with intermediate level (mild and moderate) of renal impairment.
2,030 studies on the registry are indexed under Renal Insufficiency; 168 are open to participants now.
This study's enrollment of 23 is below the median of 43 across 1,534 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
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-Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method)
-Subjects with renal impairment: The subject has any form of renal dysfunction which includes polycystic kidney disease
The subject is classified as having renal impairment at Screening according to Cockroft-Gault method for estimating creatinine clearance:
Severe: CLCr ≤ 29 mL/min Moderate: 30 mL/min ≤ CLCr ≤ 59 mL/min Mild: 60 mL/min ≤ CLCr ≤ 89 mL/min
Exclusion Criteria:
-The subject has previously been dosed with Lu AF35700
Drug: Lu AF35700
Drug: Lu AF35700
Drug: Lu AF35700
Drug: Lu AF35700
Single dose, 10 mg film coated tablet
AUC0-inf
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity
Time frame: Predose to day 57 postdose
Cmax
Maximum observed plasma concentration of Lu AF35700
Time frame: Predose to day 57 postdose
Ran from Jul 2017 to primary completion in Jul 2019, 23 months.
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This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lu AF35700