To Evaluate Safety, Tolerability, Plasma Drug Levels And Other Biological Effects In Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT01045863|
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : January 11, 2010
Last Update Posted : August 4, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: PF-03382792 Cohort 1 Drug: PF-03382792 Cohort 2 Drug: PF-03382792 Drug: Food Effect cohort Drug: CSF cohort||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 1, First-Into-Human, Escalating Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-03382792 After Administration Of Single Oral Doses To Healthy Adult Subjects|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Experimental: PART A: Ascending Cohorts
Single ascending dose cross-over. (0.05, 0.15, 0.5, 1.5, 5, 15 mg)
Drug: PF-03382792 Cohort 1
First cohort for: Single oral ascending dose of PF-03382792, formulated in solution.
Drug: PF-03382792 Cohort 2
Second cohort for: Single oral ascending dose of PF-03382792, formulated in solution.
Optional cohort 3: Single oral ascending dose of PF-03382792, formulated in solution.
Experimental: PART B: Food effect
Food effect on PF-03382792 PK
Drug: Food Effect cohort
Single oral dose, cross-over to determine effect of food on PF-03382792 pharmacokinetics. Dose will be decided after reviewing data from the ascending dose portion.
Experimental: PART C: CSF Cohort
Optional CSF Cohort
Drug: CSF cohort
Single oral dose of PF-03382792 formulated in solution. Dose will be decided after reviewing data from the ascending dose portion.
- Safety endpoints include evaluation: adverse events, change from baseline in vital signs, triplicate ECG (Part A only), singlet ECG for Parts B and C. 8 hours of cardiac telemetry postdose (Part A only). [ Time Frame: For cohorts in Part A, up to 24 days; for Cohorts in Part B, up to 17; for Part C, up to 10 days ]
- Additional Safety endpoints: clinical safety laboratory endpoints, plasma cortisol and ACTH, clinical examinations, slit lamp examination. [ Time Frame: For cohorts in Part A, up to 24 days; for Cohorts in Part B, up to 17; for Part C, up to 10 days ]
- Pharmacokinetic endpoints: plasma concentration of PF 03382792 over time (eg, AUC, Cmax, Tmax, t1/2), plasma concentration of PF 03227077 over time (eg, AUC, Cmax, Tmax, t1/2). [ Time Frame: up to 72 hours post the final dose for each cohort ]
- Plasma aldosterone concentrations. [ Time Frame: For Part A and C; up to 24 hours post final dose ]
- Change and percent change from baseline in average CSF sAPP fragment concentrations over all postdose collection time points up to 8 hours. • CSF sAPP fragment concentrations over time. • CSF concentration of PF 03382792 and PF [ Time Frame: Part C only, up to 8 hours post dose ]
- 03227077 over time (eg, AUC, Cmax, Tmax). [ Time Frame: Part C only, up to 8 hours post dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045863
|United States, Connecticut|
|Pfizer Investigational Site|
|New Haven, Connecticut, United States, 06511|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|