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To Evaluate Safety, Tolerability, Plasma Drug Levels And Other Biological Effects In Healthy Volunteers

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01045863
First received: January 8, 2010
Last updated: August 3, 2010
Last verified: August 2010
History of Changes

January 8, 2010
August 3, 2010
February 2010
June 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01045863 on ClinicalTrials.gov Archive Site
  • Plasma aldosterone concentrations. [ Time Frame: For Part A and C; up to 24 hours post final dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 03227077 over time (eg, AUC, Cmax, Tmax). [ Time Frame: Part C only, up to 8 hours post dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
To Evaluate Safety, Tolerability, Plasma Drug Levels And Other Biological Effects In Healthy Volunteers
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

The purpose of this study is to evaluate safety and tolerability after a single administration of PF-03382792 in healthy volunteers.; and to evaluate plasma drug levels and biological activity.

Evaluate the safety, tolerability, plasma concentrations of PF-03382792 and other biological activity following a single dose of PF-03382792. Three ascending single doses of PF-03382792 were administered in this study (0.05 mg, 0.15mg and 0.5 mg). The decision to terminate the study was made on June 4, 2010 due to safety findings and limitations regarding the levels of the metabolite projected for doses above 0.5 mg.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Healthy
  • 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.
  • Drug: PF-03382792
    Optional cohort 3: Single oral ascending dose of PF-03382792, formulated in solution.
  • 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.
  • Drug: CSF cohort
    Single oral dose of PF-03382792 formulated in solution. Dose will be decided after reviewing data from the ascending dose portion.
  • Experimental: PART A: Ascending Cohorts
    Single ascending dose cross-over. (0.05, 0.15, 0.5, 1.5, 5, 15 mg)
    Interventions:
    • Drug: PF-03382792 Cohort 1
    • Drug: PF-03382792 Cohort 2
    • Drug: PF-03382792
  • Experimental: PART B: Food effect
    Food effect on PF-03382792 PK
    Intervention: Drug: Food Effect cohort
  • Experimental: PART C: CSF Cohort
    Optional CSF Cohort
    Intervention: Drug: CSF cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
  • Signs or symptoms of adrenal insufficiency.
  • Ocular lens (eye) abnormalities.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01045863
B1651001
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP