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NCT01469481
An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance And Metabolism Of [14c]-PF-04991532 In Healthy Adult Male Subjects
Phase 1 trial testing PF-04991532 in Healthy in 6 participants. Completed in 1 November 2011.
1 November 2011
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 6 |
| Start date | 1 November 2011 |
| Primary completion | 1 November 2011 |
| Estimated completion | 1 November 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PF-04991532 — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Pfizer — full company profile →
Who can join
Adults 18 to 55, male only, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
Time frame: 0-168 hrs -
Metabolic Profiling/identification and determination of relative abundance of PF-04991532 and the metabolites of PF-04991532 in plasma, urine, and feces.
Time frame: 0-168 hrs -
radioactivity AUC
Time frame: 0-168 hrs -
plasma PF-04991532 AUC
Time frame: 0-168 hrs -
radioactivity Cmax
Time frame: 0-168 hrs -
plasma PF-04991532 Cmax
Time frame: 0-168 hrs
Sponsor's own description
The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of \[14C\]PF-04991532 in healthy adult male subjects.
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 NCT01469481
- 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 NCT01469481 (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 Pfizer
- Last refreshed: 27 January 2012
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/NCT01469481.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing