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NCT01770886: UE2343
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral UE2343 in Healthy Subjects
Phase 1 trial testing UE2343 in Healthy in 48 participants. Completed in 1 July 2013.
1 July 2013
Quick facts
| Lead sponsor | University of Edinburgh |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 1 January 2013 |
| Primary completion | 1 July 2013 |
| Estimated completion | 1 July 2013 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- UE2343 — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
University of Edinburgh
Who can join
Adults 18 to 65, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety and tolerability of UE2343 in healthy male/female subjects
Time frame: At each dose
Days 1-2 at each dose: * 12 lead ECG * Vital signs * Symptom led clinical assessment (day 1 only) * Routine laboratory assessments Days 3-6 at each dose: * 12 lead ECG * Vital signs * Routine laboratory assessments Day 10 at each dose: * 12 lead ECG * Vital signs * Routine laboratory assessments * Physical examination * Pregnancy test
Sponsor's own description
A randomised, double-blind, placebo-controlled, phase I study in healthy subjects. Safety, pharmacokinetic and pharmacodynamic data will be collected.
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 NCT01770886
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01770886 (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 University of Edinburgh
- Last refreshed: 16 July 2013
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/NCT01770886.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing