A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Kidney Problems
Renal Insufficiency · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05718648 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 1015550 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) |
3347.73; 2590.32; 3141.86; 2285.92 | — |
| PRIMARY Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) |
4367.05; 3312.70; 3841.47; 3014.58 | — |
| PRIMARY Maximum Measured Concentration of R-BI 1015550 in Plasma (Cmax) |
399.46; 464.19; 367.36; 380.43 | — |
| PRIMARY Maximum Measured Concentration of BI 1015550 in Plasma (Cmax) |
404.41; 486.36; 359.75; 397.56 | — |
| SECONDARY Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
3391.98; 2638.63; 3177.31; 2333.59 | — |
| SECONDARY Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
4280.84; 3423.14; 3941.06; 3112.82 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Inclusion criteria applying to all participants:
- Male or female participants
- Age of 18-79 years (inclusive)
- Body mass index (BMI) of 18.5 to 35.0 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Male participants are not required to use contraception
- Women of child-bearing potential (WOCBP) are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 7 days after trial completion.
Of note, oral hormonal contraceptives are not considered as highly effective in this study due to the potential CYP3A induction by BI 1015550. Therefore, 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 liter (U/L) and oestradiol below 30 nanograms/liter (ng/L) is confirmatory).
Further inclusion criteria apply.
Exclusion Criteria
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 (GI) tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- Diseases of the central nervous system (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder)
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Relevant chronic or acute infections
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin or in situ carcinoma of uterine cervix
- History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
- Use of drugs within 30 days (or 5 of their half-lives, whichever is longer) of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QT interval corrected for heart rate (QTc) interval prolongation) Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT05718648). 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.