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NCT01503866
A Phase I Study to Investigate the Absorption, Metabolism and Excretion in Healthy Male Subjects
Phase 1 trial testing bardoxolone methyl in Healthy in 6 participants. Completed in 31 December 2011.
31 December 2011
Quick facts
| Lead sponsor | Biogen |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 6 |
| Start date | 1 December 2011 |
| Primary completion | 31 December 2011 |
| Estimated completion | 31 December 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- bardoxolone methyl — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Biogen — full company profile →
Who can join
Adults 18 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the absorption and excretion kinetics of bardoxolone methyl and to determine and characterize metabolites present in plasma, urine and feces in men following a single oral does or 20 mg of \[14C\]-bardoxolone methyl.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Bardoxolone methyl (CDDO-Me) as a therapeutic agent: an update on its pharmacokinetic and pharmacodynamic properties.
Wang YY, Yang YX, Zhe H, He ZX, et al · · 2014 · cited 187× · PMID 25364233 · DOI 10.2147/dddt.s68872
Verify or expand the search:
- PubMed search for NCT01503866
- 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 NCT01503866 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Biogen
- Last refreshed: 29 May 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/NCT01503866.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing