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NCT01984723
A Multi-Center, Open-Label Phase I Study to Investigate the Effect of Different Degrees of Renal Impairment on the Single-Dose Pharmacokinetics of EVP-6124 in Patients With Renal Impairment Compared to Subjects With Normal Renal Function
Phase 1 trial testing Experimental: EVP-6124 in Renal Impairment in 32 participants. Completed.
1 February 2014
Quick facts
| Lead sponsor | FORUM Pharmaceuticals Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 1 June 2013 |
| Primary completion | 1 February 2014 |
| Sites | 2 locations across Czechia, Hungary |
Drugs / interventions tested
- Experimental: EVP-6124 — full drug profile →
Conditions studied
- Renal Impairment — all drugs for Renal Impairment →
Sponsor
FORUM Pharmaceuticals Inc — full company profile →
Who can join
Adults 18 to 70, any sex, with Renal Impairment. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe renal impairment compared with subjects with normal renal function.
Time frame: Oral clearance of EVP-6124, Maximum plasma concentration, Terminal elimination half life, Total area under the plasma concentration time curve from time t to time infinity and Renal clearance of EVP-6124 and metabolites [Time Frame 0-288 hours postdose]
Sponsor's own description
The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe renal impairment compared with subjects with normal renal function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01984723
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07154901 — Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD23 · Phase 1 · recruiting
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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 NCT01984723 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by FORUM Pharmaceuticals Inc
- Last refreshed: 24 August 2015
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/NCT01984723.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing