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NCT00150215
An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers
Phase 1 trial testing PF-00184562 in Schizophrenia in 18 participants. Completed in 1 October 2005.
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 July 2005 |
| Estimated completion | 1 October 2005 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PF-00184562 — full drug profile →
- Olanzapine (olanzapine) — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
Pfizer — full company profile →
Who can join
Adults 18 to 55, any sex, with Schizophrenia. 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 single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).
- Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax)
- Time to obtain maximum concentration (tmax), area under concentration-time curve (AUC), and terminal half-life (t1/2).
- Exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
- All measurements to be assessed over single doses.
Sponsor's own description
The purposes of this study are: * To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and * To explore the exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
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 NCT00150215
- 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 NCT00150215 (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: 24 July 2006
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/NCT00150215.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing