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NCT04534699
Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
Phase 1 trial testing KBP-5074 in Moderate Hepatic Impairment in 12 participants. Completed in 19 November 2020.
19 November 2020
Quick facts
| Lead sponsor | KBP Biosciences |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 27 August 2020 |
| Primary completion | 19 November 2020 |
| Estimated completion | 19 November 2020 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- KBP-5074 — full drug profile →
Conditions studied
- Moderate Hepatic Impairment — all drugs for Moderate Hepatic Impairment →
- Healthy — all drugs for Healthy →
Sponsor
KBP Biosciences — full company profile →
Who can join
Adults 18 to 80, any sex, with Moderate Hepatic Impairment or Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of KBP-5074.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist Ocedurenone (KBP-5074) in Individuals with Moderate Hepatic Impairment.
McCabe J, Zhang J, Yang F, Benn V. · · 2024 · cited 1× · PMID 38329646 · DOI 10.1007/s13318-024-00879-3
Verify or expand the search:
- PubMed search for NCT04534699
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of KBP-5074
Trials testing the same drug.
- NCT04968184 — Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD) · Phase 3 · terminated
- NCT04634812 — Mass Balance Study of KBP-5074 in Healthy Male Subjects · Phase 1 · completed
- NCT04606537 — Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects · Phase 1 · completed
- NCT02837237 — Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease · Phase 1 · completed
- NCT02653014 — Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment · Phase 1 · completed
Other recruiting trials for Moderate Hepatic Impairment
Currently open trials in the same condition.
- NCT07343960 — A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Imp · Phase 1 · recruiting
Other KBP Biosciences trials
Trials by the same sponsor.
- NCT05507463 — Study of KBP-7072 in Healthy Male and Female Subjects · Phase 1 · completed
- NCT04968184 — Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD) · Phase 3 · terminated
- NCT04634812 — Mass Balance Study of KBP-5074 in Healthy Male Subjects · Phase 1 · completed
- NCT04606537 — Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects · Phase 1 · completed
- NCT04532957 — A Multiple Ascending Dose Study to Investigate Safety of KBP-7072 in Healthy Subjects · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04534699 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by KBP Biosciences
- Last refreshed: 16 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04534699.
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