A Phase 1 interventional study of TNO155 in Renal Impairment, sponsored by Novartis Pharmaceuticals. Withdrawn. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Diagnostic
The purpose of this Phase 1 study is to evaluate the effect of various degrees of renal impairment on plasma pharmacokinetics (PK), safety and tolerability of TNO155. The results of this study will guide the Novartis recommendation regarding whether or not a dose adjustment may be needed when treating patients with renal impairment
This is a study to evaluate the PK of TNO155 in participants with mild, moderate or severe renal impairment compared to matched healthy control participants with normal renal function. The study will be divided into 2 parts. Participants in the renal impairment groups will be staged by their respective degree of renal function (mild, moderate, or severe) according to the estimated glomerular filtration rate (eGFR) determined at the screening visit. Each renal impairment participant must be matched to a healthy control participant with respect to age (±10 years), body weight (±20%) and sex. Each participant in the healthy control group (Group 1) can be matched to one or more participants from any renal impairment group (Groups 2, 3, and 4).
On Day 1 morning, participants will receive a single oral dose of TNO155 .All participants will be domiciled from Day -1 until Day 11. All participants should have a poststudy safety follow-up contact conducted approximately 30 days after administration of study treatment. The study will be considered complete once all the participants have finished the required assessments, dropped out, or been lost to follow-up before completing the required assessments.
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All participants Participants must weigh at least 50 kg and no more than 120 kg and must have a body mass index (BMI) within the range of 18.0 to 38.0 kg/m2, inclusive, for healthy participants. Must be a non-smoker or and agree to remain a non-smoker from screening until the End of Study.
Group 1
•eGFR as determined by Chronic Kidney Disease Epidemiology Collaboration [CKD EPI] equation and conversion within normal range as determined by GFR 90 mL/min at screening and baseline.
Groups 2 to 4
Exclusion Criteria:
All Participants
Other protocol-defined inclusion/exclusion criteria may apply
Healthy control participants with normal renal function
Drug: TNO155
Mild renal impairment
Drug: TNO155
Moderate renal impairment
Drug: TNO155
Severe renal impairment
Drug: TNO155
Single oral dose of TNO155 on Day 1
Area under the concentration-versus-time curve (AUC) from time zero to the last measurable plasma concentration (AUClast) of TNO155
AUClast will be calculated based on TNO155 plasma concentrations and non-compartmental methods.
Time frame: Up to 240 hours post single dose
AUC from time zero to time "t" (AUC0-t) of TNO155
AUC0-t will be calculated as needed based on TNO155 plasma concentrations and non-compartmental methods. The definition of time "t" may be data-driven post-hoc to mitigate treatment bias due to within participant differences in Tlast between the treatments, or may be selected to allow between-study exposure comparisons that use a common time window.
Time frame: AUC from time zero to time "t" (AUC0-t) of TNO155
AUC from time zero to infinity (AUCinf) of TNO155
AUCinf will be calculated based on TNO155 plasma concentrations and non-compartmental methods.
Time frame: Up to 240 hours post single dose
Maximum (peak) observed plasma concentration (Cmax) of TNO155
Cmax will be calculated based on TNO155 plasma concentrations and non-compartmental methods.
Time frame: Up to 240 hours post single dose
Time to reach maximum observed plasma concentration (Tmax) of TNO155
Tmax will be calculated based on TNO155 plasma concentrations and non-compartmental methods
Time frame: Up to 240 hours post single dose
Elimination half-life (T1/2) of TNO155
T1/2 will be calculated based on TNO155 plasma concentrations and non-compartmental methods.
Time frame: Up to 240 hours post single dose
Sampling time of the last measurable plasma concentration (Tlast) of TNO155
Tlast will be calculated based on TNO155 plasma concentrations and non-compartmental methods.
Time frame: Up to 240 hours post single dose
Apparent plasma clearance (CL/F) of TNO155
CL/F will be calculated based on TNO155 plasma concentrations and non-compartmental methods.
Time frame: Up to 240 hours post single dose
Apparent volume of distribution during terminal phase (Vz/F) of TNO155
Vz/F will be calculated based on TNO155 plasma concentrations and non-compartmental methods.
Time frame: Up to 240 hours post single dose
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence of AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.
Time frame: Up to 30 days post single dose
Unbound Cmax (Cmax,u) of TNO155
Cmax,u will be calculated based on the unbound fraction of TNO155 in plasma.
Time frame: Up to 240 hours post single dose
Unbound AUClast (AUClast,u) of TNO155
AUClast,u will be calculated based on the unbound fraction of TNO155 in plasma.
Time frame: Up to 240 hours post single dose
Unbound AUCinf (AUCinf,u) of TNO155
AUCinf,u will be calculated based on the unbound fraction of TNO155 in plasma
Time frame: Up to 240 hours post single dose
Unbound CL/F (CL/F,u) of TNO155
CL/F,u will be calculated based on the unbound fraction of TNO155 in plasma.
Time frame: Up to 240 hours post single dose
Renal clearance (CLr) of TNO155
CLr will be calculated based on urinary excretion data of TNO155.
Time frame: Up to 240 hours post single dose
Apparent non-renal clearance (CLNR/F) of TNO155
CLNR/F will be calculated based on urinary excretion data of TNO155.
Time frame: Up to 240 hours post single dose
Fraction of dose excreted in urine (fe) of TNO155
Fe will be calculated based on urinary excretion data of TNO155.
Time frame: Up to 240 hours post single dose
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals