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Phase 1 N=36 Treatment

A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems

Renal Insufficiency

Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) — 5014.15; 4702.56; 5099.51; 5320.64 Hours * nanomoles / Liter

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
BI 425809 (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Boehringer Ingelheim
Primary completion
Oct 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
5014.15; 4702.56; 5099.51; 5320.64; 6526.38; 5175.78
PRIMARY
Maximum Measured Concentration of Iclepertin in Plasma (Cmax)
145.06; 139.86; 177.03; 150.83; 146.15; 152.00
SECONDARY
Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
6664.69; 5661.72; 6531.93; 6405.19; 9606.90; 6580.50

Summary

This study is open to people with and without kidney problems. People can join the study if they are 18 years or older and have a body mass index (BMI) between 18.5 and 35 kg/m2. Iclepertin is a medicine that is being developed to treat diseases of the brain. The purpose of this study is to find out whether having kidney problems influences how iclepertin is taken up in the body. All participants take iclepertin once as a tablet. Participants are in the study for 2 to 3 weeks. During this time, they visit the study site 6 times. For one of the visits, participants stay 4 nights at the study site. The site staff measures the amount of iclepertin in the blood. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

Inclusion criteria applicable to all participants

  • Male or female participants
  • Age of at least 18 years (inclusive)
  • BMI of 18.5 to 35 kilogram per square metre (kg/m2) (inclusive)
  • Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial
  • Male participants are not required to use contraception
  • Woman of childbearing potential (WOCP) are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 30 days after trial completion. The following methods of contraception are considered adequate for female participants of childbearing potential:
  • Use of combined (oestrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom
  • Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
  • Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
  • Sexually abstinent
  • A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant.

Female participants are not considered to be of childbearing potential if they are either surgically sterilised (including hysterectomy) or postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle-stimulating hormone (FSH) above 40 Units per Litre (U/L) and oestradiol below 30 nanogram per Litre (ng/L) is confirmatory)

Inclusion criteria applying only to participants with impaired renal function

  • Renal impairment based on assessment of estimated Glomerular Filtration Rate (eGFR) at screening (severe renal impairment: 15-29 millilitre per minute per 1.73 square metre (mL/min/1.73 m2), moderate renal impairment: 30-59 mL/min/1.73 m2, mild renal impairment: 60-89 mL/min/1.73 m2)
  • Chronic renal impairment > 12 months (documented renal impairment indicated by reduced eGFR for more than 12 months until screening)
  • Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at both screening and check-in, with the exception of findings that in the opinion of the investigator are consistent with the participant's renal impairment
  • Medication and/or treatment regimens must have been stable (i.e., no dose adjustments) for at least 4 weeks prior to the screening period and should be kept stable until study completion. Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investigator and the sponsor's medical monitor

Inclusion criteria applying only to participants with normal renal function

  • Individually matched to participants with renal impairment according to sex, age, and weight, and race
  • eGFR ≥ 90 mL/min/1.73 m2
  • Absence of clinically significant abnormalities identified by a detailed medical history, full physical examination, vital signs and 12-lead ECG at both screening and check-in visits
  • Absence of clinically significant abnormalities identified by a laboratory test at screening visit

Exclusion criteria applying to all participants

  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics (PK) of the trial medication (except appendectomy or simple hernia repair)
  • Diseases of t
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05718843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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