CRS Clinical Research Services Kiel GmbH
Kiel, 24105, Germany
NCT Number: NCT03302091
The primary objective of the current study is to investigate the influence of moderate renal impairment on the pharmacokinetics of multiple doses in comparison to a matched control group with normal renal function.
Looking for future studies?
Notify Me18 year–79 year
All sexes
Interventional
Phase 1
Kiel, 24105, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Healthy subjects
Subjects with moderate renal impairment
For all subjects
Female subjects will not be allowed to participate if any of the following applies:
Male subjects will not be allowed to participate if any of the following applies:
28 day treatment period
Time frame: Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.
Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.
Standard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Time frame: Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.
Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).
Standard Error presented is actually geometric Standard Error.
Time frame: Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.
Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Time frame: Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.
Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Time frame: Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.
Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Time frame: Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.
Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).
Standard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00".
Boehringer Ingelheim
Industry
Pharmacokinetics, Safety and Tolerability After Multiple Dose Administration of BI 1467335 in Subjects With Moderate Renal Impairment and Subjects With Normal Renal Function (a Mono-centric, Open-label Study in Matched-group Design)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05936138
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Miami, Florida, United States
View Trial DetailsNCT07165015
Chronic Disease, Disease Attributes
Orlando, Florida, United States
View Trial DetailsNCT02653014
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Evergreen Park, Illinois, United States
View Trial DetailsNCT05718648
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Kiel, Germany
View Trial Details