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NCT01984736
A Multi-Center, Open-Label Phase I Study to Investigate the Effect of Different Degrees of Hepatic Impairment on the Single-Dose Pharmacokinetics of EVP-6124 in Patients With Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Phase 1 trial testing Experimental: EVP-6124 in Hepatic Impairment in 34 participants. Completed.
1 December 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 | 34 |
| Start date | 1 June 2013 |
| Primary completion | 1 December 2014 |
| Sites | 3 locations across Czechia, Poland, Slovakia |
Drugs / interventions tested
- Experimental: EVP-6124 — full drug profile →
Conditions studied
- Hepatic Impairment — all drugs for Hepatic Impairment →
Sponsor
FORUM Pharmaceuticals Inc — full company profile →
Who can join
Adults 18 to 65, any sex, with Hepatic 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 hepatic impairment compared with subjects with normal hepatic function.
Time frame: Oral clearance of EVP-6124, Maximum plasma concentration, Terminal elimination half life, and Total area under the plasma concentration time curve from time t to time infinity [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 hepatic impairment compared with subjects with normal hepatic 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 NCT01984736
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatic Impairment
Currently open trials in the same condition.
- NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
- NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
- NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
- NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
- NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting
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 NCT01984736 (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: 14 January 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/NCT01984736.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing