NCT00876304
Completed
Phase 1
Phase 1, Investigator And Subject-Blind, Placebo-Controlled, Randomized, Sequential Group, Multiple Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04802540 In Patients With Schizophrenia
Overview
- Phase
- Phase 1
- Intervention
- PF-04802540
- Conditions
- Schizophrenia
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to subjects with schizophrenia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males or females of non-childbearing capacity aged 18 to 55 years inclusive
- •DSM-IV diagnosis of schizophrenia, stable symptoms for at least 3 months
- •Body mass index in the range of 18 to 40 kg/m2 and body weight\>45 kg.
Exclusion Criteria
- •Evidence or history of a primary DSM IV axis I diagnosis other than schizophrenia.
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
Arms & Interventions
PF-04802540
Intervention: PF-04802540
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale
Time Frame: 22 days
Plasma concentrations of PF 04802540 and its metabolite, PF 04831035
Time Frame: 12 Days
Adverse Events
Time Frame: 22 Days
Secondary Outcomes
- Extrapyramidal Symptom Rating Scale - Abbreviated(16 days)
- Clinical Global Impression of Severity and Improvement(16 days)
- Positive and Negative Syndrome Scale(16 days)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
TAK-935 Multiple Rising Dose Study in Healthy ParticipantsEpilepsyNCT02539134Takeda40
Completed
Phase 1
A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female SubjectsImmune System Disorder (Healthy Volunteer)NCT05918588Kadmon, a Sanofi Company32
Completed
Phase 1
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on MethotrexateRheumatoid Arthritis (RA)NCT02698657Astellas Pharma Global Development, Inc.30
Completed
Phase 1
Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy ParticipantsHealthy VolunteersNCT02389881Takeda40
Completed
Phase 1
Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult VolunteersTuberculosisNCT00990990Sequella, Inc.59