A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems
Renal Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT05718843 ↗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
| Outcome | Result | p-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
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
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.