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NCT01226693
A Phase 1, Randomized, Open Label, Single Dose, 3 Treatment, Two Period, Balanced Incomplete Block Study In Healthy Fasted Volunteers To Assess The Safety, Tolerability, And Relative Oral Bioavailability Of A 6 Mg Dose Of The PH-797804 Material Sparing Tablet (MST) And Two Modified Versions Of The MST Formulation With And Without The Solubilizing Agent Sodium Lauryl Sulphate (SLS)
Phase 1 trial testing PH-797804 material sparing tablet in Healthy in 18 participants. Completed in 1 March 2011.
1 March 2011
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 18 |
| Start date | 1 November 2010 |
| Primary completion | 1 March 2011 |
| Estimated completion | 1 March 2011 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- PH-797804 material sparing tablet — full drug profile →
- PH-797804 Phase2b/3 with sodium lauryl sulphate — full drug profile →
- PH-797804 Phase2b/3 with sodium lauryl sulphate — full drug profile →
- PH-797804 material sparing tablet — full drug profile →
- PH-797804 material sparing tablet — full drug profile →
- PH-797804 Phase2b/3 without sodium lauryl sulphate — full drug profile →
- PH-797804 Phase2b/3 without sodium lauryl sulphate — full drug profile →
- PH-797804 material sparing tablet — full drug profile →
- PH-797804 Phase2b/3 without sodium lauryl sulphate — full drug profile →
- PH-797804 Phase2b/3 with sodium lauryl sulphate — full drug profile →
- PH-797804 Phase2b/3 with sodium lauryl sulphate — full drug profile →
- PH-797804 Phase2b/3 without sodium lauryl sulphate — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Pfizer — full company profile →
Who can join
Adults 21 to 55, 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.
-
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Time frame: predose to day 7 of treatment period -
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: predose to day 7 of treatment period -
Maximum observed concentration within the dosing interval (Cmax)
Time frame: predose to day 7 of treatment period -
Time for Cmax (Tmax)
Time frame: predose to day 7 of treatment period -
Terminal half-life (t1/2)
Time frame: predose to day 7 of treatment period
Sponsor's own description
There is no difference in the rate and extent of absorption of the material sparing tablet (MST), the Phase2b/3 formulation (P2b/3) with sodium lauryl sulphate (SLS) and the p2b/3 formulation without SLS.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
An overview of mammalian p38 mitogen-activated protein kinases, central regulators of cell stress and receptor signaling.
Han J, Wu J, Silke J. · · 2020 · cited 103× · PMID 32612808 · DOI 10.12688/f1000research.22092.1
Verify or expand the search:
- PubMed search for NCT01226693
- 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 NCT01226693 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Pfizer
- Last refreshed: 9 March 2011
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/NCT01226693.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing